Fulvestrant + Binimetinib for Breast Cancer
Recruiting in Palo Alto (17 mi)
+220 other locations
Overseen byBora Lim
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: National Cancer Institute (NCI)
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing whether adding binimetinib to the usual treatment of fulvestrant can help patients with a specific type of advanced breast cancer. Fulvestrant works by blocking estrogen receptors on cancer cells, while binimetinib stops enzymes that help cancer grow. The goal is to see if this combination can better control the cancer compared to using fulvestrant alone.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, concurrent anticancer therapy is not allowed, so you may need to stop any current cancer treatments. Please consult with the trial team for specific guidance on your medications.
What data supports the idea that Fulvestrant + Binimetinib for Breast Cancer is an effective treatment?
The available research shows that Fulvestrant is effective in treating advanced breast cancer, especially in postmenopausal women. It has been compared to other drugs like anastrozole and tamoxifen, showing similar or better results in patients whose cancer progressed after previous treatments. Although the research does not specifically mention Binimetinib, Fulvestrant alone has demonstrated positive outcomes in clinical trials, suggesting its potential effectiveness when combined with other treatments.
12345What safety data is available for the treatment of Fulvestrant and Binimetinib in breast cancer?
The safety data for Fulvestrant, also known as Faslodex, indicates that it is generally well tolerated in the treatment of advanced breast cancer. In various studies, including the Compassionate Use Program and clinical trials, adverse events leading to discontinuation were low, with only 1.5% to 5% of patients discontinuing due to adverse effects. Fulvestrant has been used effectively as a first to sixth-line treatment, with a clinical benefit rate ranging from 27% to 46% depending on the line of treatment. However, specific safety data for the combination of Fulvestrant and Binimetinib is not provided in the available research.
14678Is the drug Fulvestrant (Faslodex) a promising treatment for breast cancer?
Yes, Fulvestrant (Faslodex) is a promising drug for treating breast cancer. It has shown effectiveness in patients with advanced breast cancer, especially those who have already tried other treatments. It works by blocking estrogen, which can help slow down or stop the growth of cancer cells. Many patients have experienced stable disease for several months, and it is well-tolerated with few side effects.
456910Eligibility Criteria
This trial is for adults with hormone receptor-positive metastatic breast cancer that has an NF1 genetic change. Participants must have had prior treatment with fulvestrant, can have one chemotherapy line in the metastatic setting, and need to be able to undergo a biopsy. They should not be pregnant, have untreated brain metastasis, severe autoimmune diseases, or any condition that could affect the study's safety.Inclusion Criteria
I have been active and mostly self-sufficient in the last 2 weeks.
My tumor is positive for estrogen or progesterone receptors.
I have had only one chemotherapy treatment for my cancer after it spread.
+16 more
Exclusion Criteria
My brain metastasis has been stable for at least 1 month after treatment.
I am not currently receiving any cancer treatments.
You have factors that increase the chance of developing a retinal vein occlusion.
+7 more
Participant Groups
The study compares standard hormonal therapy (fulvestrant) alone versus combining it with binimetinib—a drug targeting enzymes involved in cell growth—in patients whose tumors carry an NF1 mutation. The goal is to see if adding binimetinib improves tumor shrinkage and delays progression compared to fulvestrant alone.
3Treatment groups
Experimental Treatment
Active Control
Group I: Cohort II (fulvestrant, binimetinib)Experimental Treatment9 Interventions
Patients receive fulvestrant IM on day 1 of each cycle and binimetinib PO BID on days 15-28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, MRI, or bone scan, ECHO or MUGA and tumor biopsy, as well as possible blood sample collection during screening and on study.
Group II: Cohort I (Arm I) (fulvestrant, binimetinib)Experimental Treatment9 Interventions
Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles and binimetinib PO BID on days 15 to 28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT, MRI, or bone scan, ECHO or MUGA, and tumor biopsy, as well as possible blood sample collection during screening and on study.
Group III: Cohort I (Arm II)Active Control8 Interventions
Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who progress on fulvestrant alone may migrate to cohort II if they meet the migration eligibility criteria. Patients not willing to migrate to cohort II will have further therapy at the investigator's discretion. Patients undergo a CT, MRI, or bone scan and tumor biopsy, as well as ECHO or MUGA and possible blood sample collection during screening and on study.
Fulvestrant is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Faslodex for:
- Hormone receptor-positive metastatic breast cancer
- Locally advanced breast cancer
🇺🇸 Approved in United States as Faslodex for:
- Hormone receptor-positive metastatic breast cancer
- Locally advanced breast cancer
🇨🇦 Approved in Canada as Faslodex for:
- Hormone receptor-positive metastatic breast cancer
- Locally advanced breast cancer
🇯🇵 Approved in Japan as Faslodex for:
- Hormone receptor-positive metastatic breast cancer
- Locally advanced breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
National Institutes of Health Clinical CenterBethesda, MD
NRG OncologyPhiladelphia, PA
Aurora BayCare Medical CenterGreen Bay, WI
Dayton Physician LLC-Miami Valley Hospital NorthDayton, OH
More Trial Locations
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Who Is Running the Clinical Trial?
National Cancer Institute (NCI)Lead Sponsor
NRG OncologyCollaborator
References
Comparison of fulvestrant versus tamoxifen for the treatment of advanced breast cancer in postmenopausal women previously untreated with endocrine therapy: a multinational, double-blind, randomized trial. [2022]To evaluate the efficacy and tolerability of fulvestrant (Faslodex; AstraZeneca Pharmaceuticals LP, Wilmington, DE), a new estrogen receptor (ER) antagonist that downregulates ER and has no agonist effects, versus tamoxifen, an antiestrogen with agonist and antagonist effects, for the treatment of advanced breast cancer in postmenopausal women.
A meta-analysis of clinical benefit rates for fulvestrant 500 mg vs. alternative endocrine therapies for hormone receptor-positive advanced breast cancer. [2020]Fulvestrant, a selective estrogen receptor degrader, is approved for first- and second-line treatment of postmenopausal women with hormone receptor-positive advanced breast cancer (ABC).
Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: results of a North American trial. [2022]To compare the efficacy and tolerability of fulvestrant (formerly ICI 182,780) with anastrozole in the treatment of advanced breast cancer in patients whose disease progresses on prior endocrine treatment.
Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. [2022]To compare the efficacy and tolerability of fulvestrant (formerly ICI 182,780) and anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment.
Fulvestrant ('Faslodex') in heavily pretreated postmenopausal patients with advanced breast cancer: single centre clinical experience from the compassionate use programme. [2018]Fulvestrant (Faslodex) is an oestrogen receptor (ER) antagonist with demonstrated efficacy in patients with advanced and pretreated breast cancer.
Fulvestrant (Faslodex) in advanced breast cancer: clinical experience from a Belgian cooperative study. [2018]Fulvestrant (Faslodex) is a new estrogen receptor (ER) antagonist with no agonist effects that is licensed for the treatment of postmenopausal women with hormone-sensitive advanced breast cancer (ABC) who have progressed/recurred on prior antiestrogen therapy. The Faslodex Compassionate Use Program (CUP) provides expanded access to fulvestrant in countries where it is not yet available for patients who are not eligible to enter clinical trials. This analysis pools data from 402 patients who received fulvestrant as part of the CUP in Belgium, predominantly as 3rd- to 5th-line endocrine therapy for ABC. Two patients experienced partial responses and 118 experienced stable disease lasting>or=6 months, resulting in an overall clinical benefit rate of 29.9%. Fulvestrant was active in patients with multiple sites of metastases, visceral metastases, human epidermal growth factor receptor 2-positive disease and after heavy endocrine pre-treatment. Fulvestrant was well tolerated, with only six patients (1.5%) discontinuing treatment following adverse events. These data support the findings of previous CUP analyses and Phase II and III trials, suggesting that fulvestrant is a valuable addition to the treatment sequence for postmenopausal women with ABC who have progressed/recurred on prior endocrine therapy.
Health-related quality of life from the FALCON phase III randomised trial of fulvestrant 500 mg versus anastrozole for hormone receptor-positive advanced breast cancer. [2019]The phase III randomised FALCON trial (NCT01602380) demonstrated improved progression-free survival with fulvestrant 500 mg versus anastrozole 1 mg in endocrine therapy-naïve postmenopausal women with hormone receptor-positive (HR+) locally advanced or metastatic breast cancer (LA/MBC). Furthermore, overall health-related quality of life (HRQoL) was maintained and comparable for fulvestrant and anastrozole. Here, we present additional analyses of patient-reported HRQoL outcomes from FALCON.
Fulvestrant ("Faslodex"): clinical experience from the Compassionate Use Programme. [2018]Fulvestrant ("Faslodex") is a new oestrogen receptor (ER) antagonist with no agonist effects that is licensed in the USA, Brazil, Europe and elsewhere for the treatment of advanced breast cancer (ABC) in postmenopausal women following progression on other endocrine agents. This report consolidates clinical experience from the "Faslodex" Compassionate Use Programme, including a total of 339 patients treated at eight cancer centres. Patients received fulvestrant as first- (n=22), second- (n=125), third- (n=105), fourth- (n=58), fifth- (n=22) or sixth-line (n=5) hormonal treatment for ABC, with two patients receiving fulvestrant after more than six other endocrine therapies. Objective response was achieved by 40 patients and stable disease lasting 6 months by 92 patients, giving overall clinical benefit (CB) in 132/339 patients (39%). The CB rate decreased as fulvestrant was used later in the sequence of endocrine treatments, from 46% (10/22) with first-line fulvestrant to 27% (6/22) with fifth-line fulvestrant. Increased benefit was found in patients with tumours expressing both ER and progesterone receptor (PgR) compared with other combinations, although good activity was reported in patients expressing either ER or PgR as well as in tumours expressing human epidermal growth factor receptor 2. Fulvestrant was well tolerated; adverse events were noted in 18/339 patients (5%). These findings concur with data from the clinical-trial setting and further support the assertion that greater benefit is derived when fulvestrant is used early in the treatment sequence.
Fulvestrant in heavily pre-treated patients with advanced breast cancer: results from a single compassionate use programme centre. [2018]Fulvestrant ('Faslodex') is an oestrogen receptor (ER) antagonist with no agonist effects. The drug was administered to heavily pre-treated patients with advanced breast cancer (ABC). Patients received Fulvestrant after disease progression (PD) on a previous endocrine treatment or as maintenance treatment after chemotherapy.
FDA drug approval summaries: fulvestrant. [2019]Patients with hormone-sensitive breast cancer who have responded to tamoxifen may receive additional benefit from a second endocrine agent following progression or relapse after tamoxifen therapy. Fulvestrant (Faslodex((R)), ICI 182780, AstraZeneca Pharmaceuticals; Wilmington, Delaware) is a selective antagonist of estrogen designed to have no estrogenic effects. Lack of aqueous solubility led to the development of a parenteral formulation for monthly intramuscular administration. Fulvestrant has been shown to inhibit the proliferative effects of estrogen on sensitive tissues in vitro and in vivo, and is without apparent measurable estrogenic activity. The data upon which marketing approval for fulvestrant was based are summarized below. Eight hundred fifty-one postmenopausal women with advanced breast cancer were enrolled in two phase III studies, 400 in a North American double-blind study and 451 in a European open-label study, comparing the efficacy and safety of fulvestrant with anastrozole. Four hundred twenty-eight patients were randomized to receive fulvestrant 250 mg monthly by intramuscular injection and 423 patients were to receive anastrozole 1 mg daily. Patients were considered hormone sensitive either by receptor status or previous response to endocrine therapy. Over 96% of patients had previously received tamoxifen, either in the adjuvant setting or as treatment for metastatic disease. The primary study end points were response rate and time to progression. Response rates for patients treated with fulvestrant were 17% and 20% in the North American and European trials, respectively, compared with 17% and 15% in the anastrozole treatment arms. There were no statistically significant differences in response rates, time to progression, or survival between treatment arms in either study. The most common adverse events attributed to the treatment (>10%) were injection-site reactions and hot flashes. Common events (1%-10%) included asthenia, headache, and gastrointestinal disturbances (nausea, vomiting, and diarrhea), as well as rash and urinary tract infections. A small increase in joint disorders was reported in the anastrozole-treated patients. On April 25, 2002, fulvestrant 250 mg by monthly intramuscular injection was approved by the U.S. Food and Drug Administration for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. Approval was based on similarity of response rates and time to progression between fulvestrant and anastrozole.