#Fulvestrant

[queretarotv]

En el mes de la lucha contra el cáncer de mama, Cofepris aprueba nuevo tratamiento para esta enfermedad

La Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris) autorizó el registro sanitario de capivasertib, un medicamento que, en combinación con fulvestrant, se utiliza para tratar el cáncer de mama avanzado en personas adultas. Este fármaco contribuye a evitar la multiplicación de células cancerosas y está indicado en pacientes cuyo cáncer reapareció o empeoró durante o…

[phonemantra-blog]

 Faslodex in Cancer Treatment Faslodex, also known by its generic name fulvestrant, is a crucial medication in the fight against certain types of breast cancer. It belongs to a class of drugs called estrogen receptor antagonists. This means it works by blocking the effects of estrogen in the body, which is a hormone that can promote the growth of breast cancer cells. What is Faslodex? faslodex Faslodex functions by binding to the estrogen receptors in cancer cells, effectively neutralizing their ability to receive signals from estrogen. This action inhibits the growth of estrogen-dependent cancer cells, an essential factor in treating hormone receptor-positive breast cancer. Conditions Treated with Faslodex Faslodex is primarily used in the treatment of hormone receptor-positive breast cancer, specifically in postmenopausal women. It is typically recommended when other hormone therapies have proven ineffective. Benefits and Efficacy The efficacy of Faslodex in treating hormone receptor-positive breast cancer is well-documented. Here are some key benefits: Tumor Suppression: Faslodex effectively suppresses the growth of estrogen-dependent cancer cells, slowing down or halting the progression of the disease. Improved Survival Rates: Studies have shown that Faslodex can lead to increased survival rates in individuals with advanced breast cancer, offering hope and extended quality of life. Lower Recurrence Risk: When used as an adjuvant therapy, Faslodex reduces the risk of cancer recurrence, providing long-term protection. Manageable Side Effects: While side effects are possible, Faslodex is generally well-tolerated, and its benefits often outweigh any adverse effects. Administration and Dosage Faslodex is typically administered via intramuscular injection, most commonly into the buttocks. The frequency of injections may vary, but it is often administered once a month, under the supervision of a healthcare provider. Side Effects and Safety While Faslodex is generally well-tolerated, like any medication, it may come with potential side effects. Common side effects include: Injection site pain or discomfort Nausea Headache Hot flashes Weakness Joint pain Alternative Treatments While Faslodex is a vital component of breast cancer treatment, it's essential to be aware of complementary therapies and alternative treatments that may enhance overall well-being. These may include: Hormone Therapies: Other hormone therapies such as aromatase inhibitors or targeted therapies like CDK4/6 inhibitors may be considered in combination with Faslodex. Chemotherapy: In certain cases, chemotherapy may be recommended alongside Faslodex. Lifestyle Changes: A healthy lifestyle, including regular exercise and a balanced diet, can complement medical treatment and improve overall health. Supportive Therapies: Counseling, support groups, and integrative therapies like acupuncture or yoga can provide emotional and physical support during treatment. Future Developments Cancer research is a dynamic field, and ongoing studies aim to enhance the efficacy and accessibility of Faslodex and similar treatments. Stay informed about the latest developments in breast cancer research, including: Clinical Trials: Learn about ongoing clinical trials exploring new treatments and combinations involving Faslodex. Emerging Therapies: Discover potential breakthroughs in breast cancer therapies and how they may impact treatment strategies. Patient Advocacy: Explore opportunities to engage in patient advocacy and contribute to advancing breast cancer care. FAQs on the topic of "Faslodex": FAQ 1: What is Faslodex used for in cancer treatment? Answer: Faslodex is primarily used to treat hormone receptor-positive breast cancer, particularly in postmenopausal women. FAQ 2: How does Faslodex work in the body? Answer: Faslodex functions by binding to estrogen receptors in cancer cells, blocking their response to estrogen and inhibiting cell growth. FAQ 3: What are the benefits of Faslodex treatment? Answer: Faslodex offers benefits such as tumor suppression, increased survival rates, reduced recurrence risk, and manageable side effects in breast cancer care. FAQ 4: Are there any side effects associated with Faslodex? Answer: Common side effects of Faslodex may include injection site discomfort, nausea, headache, hot flashes, weakness, and joint pain. Severe side effects are rare but possible. FAQ 5: How is Faslodex administered to patients? Answer: Faslodex is typically administered via intramuscular injection, often once a month, under the supervision of a healthcare provider. FAQ 6: Are there alternative treatments to Faslodex for breast cancer? Answer: Yes, alternative treatments may include other hormone therapies, chemotherapy, lifestyle changes, and supportive therapies, depending on individual circumstances. FAQ 7: Can Faslodex be used in combination with other cancer treatments? Answer: In some cases, Faslodex may be used in combination with other therapies, such as aromatase inhibitors or targeted therapies, to enhance treatment outcomes. FAQ 8: What should patients expect during Faslodex treatment? Answer: Patients can expect ongoing monitoring, potential side effects, and regular discussions with their healthcare provider to assess treatment effectiveness. FAQ 9: Are there ongoing clinical trials involving Faslodex? Answer: Yes, there are clinical trials exploring new uses and combinations of Faslodex, offering opportunities for patients to participate in cutting-edge research. FAQ 10: How can patients stay informed about the latest developments in breast cancer care, including Faslodex? Answer: Patients can stay informed by following reputable cancer support organizations, clinical trials information, and educational breast cancer resources for updates and advocacy opportunities. Conclusion In this comprehensive guide, we've explored the critical role of Faslodex in the treatment of hormone receptor-positive breast cancer. From its mechanism of action to its benefits, dosage guidelines, and patient experiences, you now have a thorough understanding of this medication.

[medicomunicare]

Clinical trials for hormone-positive resistant breast cancer: exploring kinase inhibitors and ER-modulators

Clinical trials for hormone-positive resistant breast cancer: exploring kinase inhibitors and ER-modulators

Patients with hormone receptor (ER)-positive, growth factor receptor (Her2)-negative breast cancer are commonly treated in the first line with an endocrine therapy (such as an aromatase inhibitor like anastrozole, which blocks the production of estrogens) alongside a CDK4/6 inhibitor, which stalls the cell cycle. Eventually, however, most tumors develop resistance to these therapies, and options…

[allaboutpharma]

This page contains information about Fulvestrant-D5. Buy high quality Fulvestrant-D5 from SimSon Pharma Limited

[bcisurat]

The Role of Hormone Therapy in Breast Cancer Treatment Explained By The Breast Cancer Specialist In Surat

Breast cancer remains one of the most prevalent forms of cancer affecting women worldwide. As medical science advances, treatment options continue to evolve, offering patients better chances of survival and improved quality of life. Among these treatment modalities, hormone therapy has emerged as a crucial component in the fight against breast cancer. This blog post from our breast cancer specialists in Surat at BCI- Blood and Cancer Institute, is about the significant role that hormone therapy plays in breast cancer treatment, exploring its mechanisms, applications, and impact on patient outcomes.

Understanding Hormone-Responsive Breast Cancer

Not all breast cancers are the same. A significant proportion of breast cancers are hormone-responsive, meaning their growth is fueled by hormones such as estrogen and progesterone. These cancers are often referred to as estrogen receptor-positive (ER+) or progesterone receptor-positive (PR+) breast cancers.

In hormone-responsive breast cancers, the cancer cells have receptors that bind to estrogen or progesterone, stimulating their growth and proliferation. Cancer specialists in Surat, and worldwide, use this understanding for targeted treatments that aim to disrupt this hormone-dependent growth cycle.

The Mechanism of Hormone Therapy

Hormone therapy, also known as endocrine therapy, works by interfering with the body��s hormone production or by blocking the effects of hormones on breast cancer cells. The primary goal is to deprive the cancer cells of the hormones they need to grow and spread. This can be achieved through various approaches:

Selective Estrogen Receptor Modulators (SERMs): These drugs, such as tamoxifen, work by binding to estrogen receptors in breast tissue, effectively blocking estrogen from attaching to these receptors.

Aromatase Inhibitors (AIs): In postmenopausal women, AIs like letrozole, anastrozole, and exemestane work by reducing the amount of estrogen produced in the body by blocking the enzyme aromatase, which is responsible for converting androgens into estrogen.

Estrogen Receptor Downregulators: Drugs like fulvestrant not only block estrogen receptors but also cause the receptors to be destroyed, further reducing the cancer cells’ ability to respond to estrogen.

Ovarian Suppression: In premenopausal women, medications or surgical procedures can be used to stop the ovaries from producing hormones, effectively inducing menopause.

Applications of Hormone Therapy

Hormone therapy finds application at various stages of breast cancer treatment in Surat:

Adjuvant Therapy: After primary treatments like surgery, radiation, or chemotherapy, hormone therapy is often prescribed to reduce the risk of cancer recurrence. This can be a long-term treatment, often lasting 5–10 years.

Neoadjuvant Therapy: In some cases, hormone therapy may be used before surgery to shrink tumors, making them easier to remove and potentially allowing for breast-conserving surgery.

Metastatic Breast Cancer Treatment: For patients with advanced or metastatic hormone-responsive breast cancer, hormone therapy can be an effective way to control the disease, often with fewer side effects than traditional chemotherapy.

Preventive Therapy: In high-risk individuals, certain hormone therapies have shown promise in reducing the risk of developing breast cancer.

Benefits and Considerations

The benefits of hormone therapy in breast cancer treatment are substantial:

● Improved Survival Rates: Studies have shown that hormone therapy can significantly reduce the risk of cancer recurrence and improve overall survival rates in patients with hormone-responsive breast cancers.

● Quality of Life: Compared to chemotherapy, hormone therapy often has fewer and less severe side effects, allowing patients to maintain a better quality of life during treatment.

● Long-term Protection: The protective effects of hormone therapy can extend for many years after the completion of treatment.

However, it’s important to consider that hormone therapy is not without its challenges:

● Side Effects: While generally milder than chemotherapy, hormone therapy can cause side effects such as hot flashes, joint pain, and increased risk of osteoporosis.

● Resistance: Some cancers may develop resistance to hormone therapy over time, necessitating changes in treatment approach.

● Patient Adherence: The long-term nature of hormone therapy can be challenging for some patients, affecting adherence to treatment plans.

Personalized Approach

According to the experts of Blood and Cancer Institute, one of the best cancer hospitals in Surat, the field of breast cancer treatment is moving towards increasingly personalized approaches. Factors such as the specific type of breast cancer, the patient’s menopausal status, and individual risk factors all play a role in determining the most appropriate hormone therapy regimen.

Genomic testing has further refined this approach, allowing oncologists to identify patients who are most likely to benefit from hormone therapy and those who might safely forego it, avoiding unnecessary treatment and potential side effects.

Conclusion

Hormone therapy has revolutionized the treatment of hormone-responsive breast cancers, offering patients a targeted, effective, and often less toxic treatment option. As research continues, we can expect further refinements in hormone therapy approaches, leading to even better outcomes for breast cancer patients.

The role of hormone therapy in breast cancer treatment underscores the importance of personalized medicine and the power of understanding the underlying biology of cancer. As we continue to unravel the complexities of breast cancer, hormone therapy stands as a testament to the progress made in cancer treatment and the hope it brings to millions of patients worldwide.

[drcare4u]

FDA Approves Itovebi Combo for Some With Advanced Breast Cancer

The FDA has approved an Itovebi combination for select patients with advanced or metastatic breast cancer. The Food and Drug Administration (FDA) has approved Itovebi (inavolisib) with Ibrance (palbociclib) and Faslodex (fulvestrant) for certain patients with advanced or metastatic breast cancer. Specifically, the Itovebi regimen is for the treatment of adult patients with endocrine-resistant,…

[stevenwilliam12]

Market Insights into HR-positive/HER2-negative Breast Cancer: Future Therapies Shaping the Landscape

Introduction

HR-positive/HER2-negative breast cancer is the most prevalent subtype of breast cancer, representing approximately 70% of all cases. Characterized by the presence of hormone receptors and the absence of the HER2 protein, this subtype typically responds well to hormone therapies. However, challenges remain, particularly concerning treatment resistance and recurrence. With ongoing advancements in targeted therapies, the treatment landscape for HR-positive/HER2-negative breast cancer is evolving rapidly, offering hope for improved patient outcomes and quality of life.

Current Landscape of HR-positive/HER2-negative Breast Cancer Treatment

The management of HR-positive/HER2-negative breast cancer has traditionally relied on hormone-based therapies aimed at inhibiting estrogen's effect on tumor growth. Common treatments include:

Tamoxifen: A selective estrogen receptor modulator (SERM) used mainly in premenopausal women.

Aromatase Inhibitors: Such as letrozole and anastrozole, which reduce estrogen production in postmenopausal women.

Fulvestrant: A selective estrogen receptor degrader (SERD) that downregulates estrogen receptors.

Despite their effectiveness, many patients experience disease recurrence, prompting researchers to explore new therapeutic options that can address resistance mechanisms and enhance treatment efficacy.

Emerging Therapies Transforming the Market

The HR-positive/HER2-negative breast cancer market is witnessing a wave of innovative therapies that aim to improve patient outcomes. Key emerging therapies include:

1. CDK4/6 Inhibitors

Examples: Palbociclib, ribociclib, abemaciclib.

Mechanism: These drugs inhibit cyclin-dependent kinases 4 and 6, proteins critical for cell division. In clinical trials, CDK4/6 inhibitors combined with endocrine therapy have demonstrated significant improvements in progression-free survival for patients with advanced HR-positive breast cancer.

Market Impact: The integration of these inhibitors into treatment regimens has reshaped standard care for metastatic HR-positive breast cancer, leading to increased demand and growth in this segment of the market.

2. PI3K Inhibitors

Example: Alpelisib.

Mechanism: Targeting the PI3K/AKT/mTOR signaling pathway, which is often activated in HR-positive tumors, alpelisib has been approved for use in combination with endocrine therapy for patients with PIK3CA-mutated tumors. This targeted approach addresses specific genetic alterations that contribute to treatment resistance.

Market Potential: As genetic profiling becomes more common in clinical practice, the demand for PI3K inhibitors is expected to rise, offering personalized treatment options for patients.

3. Next-Generation SERDs

Example: Elacestrant.

Mechanism: Next-generation SERDs are designed to more effectively degrade estrogen receptors and block estrogen's proliferative effects. These oral agents provide a more convenient alternative to intramuscular fulvestrant.

Market Growth: As clinical trials continue to show efficacy, next-generation SERDs may become a preferred option in the treatment of HR-positive breast cancer, expanding their market share.

4. BCL-2 Inhibitors

Example: Venetoclax.

Mechanism: BCL-2 inhibitors induce apoptosis in cancer cells by inhibiting proteins that prevent cell death. Early studies suggest that combining venetoclax with hormonal therapies may enhance treatment effectiveness, particularly in cases of resistant disease.

Emerging Role: The potential for BCL-2 inhibitors to improve outcomes in HR-positive/HER2-negative breast cancer could contribute significantly to market expansion.

5. Combination Therapies

Trend: The future of HR-positive/HER2-negative breast cancer treatment is increasingly focused on combination therapies that leverage the strengths of multiple agents. Pairing CDK4/6 inhibitors with aromatase inhibitors or other targeted therapies can provide a more robust approach to combating resistant disease.

Market Outlook: The trend toward combination therapies is likely to drive innovation and growth in the HR-positive/HER2-negative breast cancer market, as new treatment regimens are developed and tested.

The Role of Biomarkers and Personalized Medicine

As understanding of tumor biology advances, the importance of biomarkers in tailoring treatment strategies is becoming clear. Identifying genetic mutations and alterations, such as PIK3CA or ESR1 mutations, enables healthcare providers to select therapies that align with the unique characteristics of each patient’s cancer. This personalized approach is expected to improve treatment efficacy and reduce unnecessary side effects.

Market Challenges and Considerations

Despite the promising developments, the HR-positive/HER2-negative breast cancer market faces several challenges:

Drug Resistance: Ongoing resistance to current therapies remains a critical concern, necessitating the development of novel agents that can overcome this barrier.

Cost of Treatment: New therapies often come with high price tags, limiting accessibility for some patients and posing challenges for healthcare systems.

Clinical Trials and Approvals: Continuous research and clinical trials are essential to bring new treatments to market, ensuring they are safe and effective for patients.

Conclusion: The Future of HR-positive/HER2-negative Breast Cancer Treatment

The landscape of HR-positive/HER2-negative breast cancer treatment is rapidly evolving, with a host of emerging therapies poised to reshape care. As new drugs enter the market and personalized medicine continues to gain traction, patients can look forward to improved treatment options and outcomes. Continued investment in research and development, along with the integration of advanced technologies for biomarker identification, will be crucial in driving future growth in this dynamic market.

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[indianph]

Palbociclib can interact with other medications, potentially affecting its efficacy or safety. For instance, strong CYP3A inhibitors and inducers can alter palbociclib 125 mg price and drug levels in the body and should be used cautiously. Additionally, medications that elevate gastric pH may reduce Palbociclib’s effectiveness. However, no significant interactions have been observed with drugs like letrozole, fulvestrant, or goserelin. Proper understanding of these interactions is vital for safe treatment. For detailed information on drug interactions and pricing, feel free to contact us via Call/WhatsApp: +91 8130290915.

[global-online-pharmacy]

Ribociclib Kisqali Medication uses, side effects & Lowest cost

Ribociclib is used in combination with another medication to treat a certain type of hormone receptor– positive (depends on hormones such as estrogen to grow) advanced breast cancer or that has spread to other parts of the body in women who have not experienced menopause (change of life; end of monthly menstrual periods) and in those who are close to or who have already experienced menopause. Ribociclib is also used in combination with fulvestrant (Faslodex) to treat a certain type of hormone receptor–positive advanced breast cancer or that has spread to other parts of the body as an initial treatment or in people who have not been treated successfully with other treatments in women who have already experienced menopause.

How should this medicine be used?

Ribociclib comes as a tablet to take by mouth. It is usually taken with or without food once daily in the morning for the first 21 days of a 28-day cycle. Take ribociclib at around the same time every day.

What side effects can this medication cause?

Ribociclib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: diarrhea constipation, stomach pain, headache, hair loss, back pain itching, mouth sores, swelling of the hands, feet, ankles, or lower legs difficulty falling asleep or staying asleep

Above content source:  https://www.911globalmeds.com/info/213-1-Ribociclib-Kisqali-Kryxana-Medication-Patient-Information-In-English.pdf

The guaranteed Lowest Cost of Ribociclib / Kisqali 200 mg @ $34.05 and $6.50 per Tablet Online.

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[bidhuan]

FDA Memberikan Peninjauan Prioritas untuk Inavolisib dalam Pengobatan Kanker Payudara dengan Mutasi PIK3CA

Majalah Farmasetika – Peninjauan prioritas inavolisib adalah untuk pengobatan pasien dengan kanker payudara lanjut yang reseptor hormonnya positif, HER2-negatif dengan mutasi PIK3CA. FDA telah memberikan peninjauan prioritas untuk inavolisib (GDC-0077; Roche) dalam kombinasi dengan palbociclib (Ibrance; Pfizer) dan fulvestrant (Faslodex; AstraZeneca), mempercepat aksesibilitas bagi pasien yang…

[arrangoiz]

Monaleesa-3 Trial in Metastatic Breast Cancer

The CDK 4/6 inhibitors are a class of oral drugs that have been approved for HR+, HER2-negative metastatic breast cancer in the first-line setting or after progression on prior aromatase inhibitor In the MONALEESA-3 trial: Ribociclib in combination with fulvestrant: Showed progression-free survival (20.5 months vs. 12.8 months) and overall survival benefit over fulvestrant alone in HR+,…

[novaglobalhealthcare]

FDA approves capivasertib with fulvestrant for breast cancer

On November 16, 2023, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca Pharmaceuticals) with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

FDA also approved the FoundationOne®CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with capivasertib with fulvestrant.

The full prescribing information for Truqap will be posted here.

Efficacy was evaluated in CAPItello-291 (NCT04305496), a randomized, double-blind, placebo-controlled, multicenter trial in 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer, of which 289 patients had tumors with PIK3CA/AKT1/PTEN-alterations. All patients were required to have progression on aromatase inhibitor-based treatment. Patients could have received up to two prior lines of endocrine therapy and up to 1 line of chemotherapy for locally advanced or metastatic disease.

Patients were randomized (1:1) to either capivasertib 400 mg or placebo administered orally twice daily for 4 days, followed by 3 days off treatment each week over a 28-day treatment cycle. Both investigational and control arm patients received Fulvestrant 500 mg intramuscularly on cycle 1 days 1 and 15, and then every 28 days thereafter. Patients received therapy until disease progression or unacceptable toxicity.

The major efficacy outcome measure was investigator-assessed progression-free survival (PFS) in the overall population and in the population of patients whose tumors had PIK3CA/AKT1/PTEN-alterations evaluated according to RECIST, version 1.1. A statistically significant difference in PFS was observed in the overall population and in the population of patients whose tumors have PIK3CA/AKT1/PTEN-alteration(s).

In the 289 patients with PIK3CA/AKT1/PTEN-altered tumors, the median PFS was 7.3 months (95% CI: 5.5, 9.0) in the capivasertib-fulvestrant group and 3.1 months (95% CI: 2.0, 3.7) in the placebo-fulvestrant group (Hazard Ratio [HR] 0.50 [95% CI: 0.38, 0.65] p-value< 0.0001).

An exploratory analysis of PFS in the 313 (44%) patients whose tumors did not have a PIK3CA/AKT1/PTEN-alteration showed a HR of 0.79 (95% CI: 0.61, 1.02), indicating that the difference in the overall population was primarily attributed to the results seen in the population of patients whose tumors have PIK3CA/AKT1/PTEN-alteration.

The most common adverse reactions (reported in ≥20% of patients), including laboratory abnormities were diarrhea, cutaneous adverse reactions, increased random glucose, decreased lymphocytes, decreased hemoglobin, increased fasting glucose, nausea, fatigue, decreased leukocytes, increased triglycerides, decreased neutrophils, increased creatinine, vomiting and stomatitis.

The recommended capivasertib dose is 400 mg orally twice daily (approximately 12 hours apart), with or without food, for 4 days followed by 3 off days until disease progression or unacceptable toxicity.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), Health Canada, Israel’s Ministry of Health (IMoH), Singapore’s Health Sciences Authority (HSA), Switzerland's Swissmedic, and United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA). The application reviews are ongoing at the other regulatory agencies.

[smiithwalkerr]

Abemaciclib in combination with fulvestrant for advanced or metastatic breast cancer after prior endocrine therapy

Breast cancer, a cancer that develops from the tissues of the breast, is the most common cancer in the UK. There are many types of breast cancer and they are often grouped based on the presence or absence of some specific types of proteins (‘receptors’) in the cells of the patient. The most common type of breast cancer are those that are hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-). The advanced form of the HR+ and HER2- breast cancer occurs when the cancer has spread to other parts of the body such as the bones, brain and liver.

Abemaciclib is a new drug that is being developed for patients with the HR+/HER2- type of advanced breast cancer. The drug is being developed to be given in combination with fulvestrant, a drug that is already in use for the treatment of advanced breast cancer. Abemaciclib works differently from other drugs by targeting a very specific type of enzyme produced by cancer cells in patients with HR+/HER2- breast cancer. Abemaciclib is taken orally while fulvestrant is given by injection. If approved, the combination of both drugs will offer additional treatment options for patients with advanced HR+/HER2- breast cancer that have not responded well to other drugs.

[larvolclinic9]

Sorafenib and Fulvestrant in Treating Patients With Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Aromatase Inhibitor

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving sorafenib together with fulvestrant may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving sorafenib together with fulvestrant works in treating patients with locally advanced or metastatic breast cancer that did not respond to aromatase inhibitor therapy.Condition or disease Intervention/treatment Phase Breast CancerDrug: fulvestrantDrug: sorafenib tosylatePhase 2

Detailed Description:

OBJECTIVES:

Primary

To investigate the clinical activity of sorafenib tosylate and fulvestrant, as determined by a 4-month progression-free survival rate, in patients with hormone receptor-positive locally advanced or metastatic breast cancer that progressed after prior treatment with an aromatase inhibitor.

Secondary

To determine the objective response rate in patients treated with this regimen.

To determine the median time to progression in patients treated with this regimen.

To determine the progression-free survival of patients treated with this regimen.

To determine the overall survival of patients treated with this regimen.

To establish the safety and tolerability profile of this regimen in these patients.

OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Patients also receive fulvestrant intramuscularly on days 1 and 15 of course 1 and on day 1 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 28-56 days.

Study Design

MedlinePlus Genetics related topics: Breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Fulvestrant Sorafenib

Genetic and Rare Diseases Information Center resources: Breast Cancer, Male

U.S. FDA Resources