Futibatinib plus Fulvestrant for Breast Cancer

Phase-Based Estimates
AOU Policlinico - Vittorio Emanuele, Catania, Italy
Breast Cancer+3 More
Futibatinib plus Fulvestrant - Drug
All Sexes
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether a drug may help treat breast cancer.

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Eligible Conditions

  • Breast Cancer
  • Breast Neoplasms
  • Metastatic Breast Cancer
  • FGFR 1 High Amplification
  • FGFR2 Amplification

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Futibatinib plus Fulvestrant will improve 3 primary outcomes and 13 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of 12 months (estimated).

12 months
6-month Progression-free Survival (PFS) rate
6-month Progression-free Survival (PFS) rate - Cohorts 1-3
Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR) - Cohort 1,2, and 4
Complete Response (CR)
Duration of Response (DOR)
Number of Adverse Events (AEs) Related to Futibatinib as a monotherapy and in combination with Fulvestrant
Number of Adverse Events (AEs) Related to TAS-120 as a monotherapy and in combination with Fulvestrant
Overall Response Rate (ORR)
Overall Survival (OS)
Progression-free Survival (PFS)
12 months (estimated)
6-month Progression-free Survival (PFS) rate - Cohort 4
Clinical Benefit Rate (CBR) - Cohort 3
Complete Response (CR) - Cohort 3
Objective Response Rate (ORR) - Cohorts 1, 2
Overall Response Rate (ORR) - Cohort 4

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

No Control Group

This trial requires 168 total participants across 2 different treatment groups

This trial involves 2 different treatments. Futibatinib Plus Fulvestrant is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Group/Cohort 1 Description HR+ HER2- Measurable Disease w/ FGFR2 Amplification Group/Cohort 2 Description TNBC Measurable Disease w/ FGFR2 Amplification Group/Cohort 3 Description HR+ HER2- or TNBC Non-Measurable Disease w/ FGFR2 Amplification
Futibatinib plus FulvestrantGroup/Cohort 4 Description HR+ HER2- Measurable Disease w/ FGFR1 Amplification

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Closest Location

Tom Baker Cancer Center - Calgary, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Breast Cancer or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Measurable disease per RECIST 1.1
Provide written informed consent
Age ≥ 18 years of age
A. Cohort 1
HR+ HER2- breast cancer harboring an FGFR2 gene amplification.
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Has received 1-3 prior endocrine-containing therapies and up to 2 prior chemotherapy regimens for advanced/metastatic disease
Has received prior treatment with a CDK4/6 inhibitor or is ineligible for such treatment
B. Cohort 2
TNBC harboring an FGFR2 gene amplification

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of breast cancer?

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Menses irregularity, changes in the size, appearance, and weight of breasts, nipple discharge with or without pain, nipple lump with or without a nipple lesion, or persistent pain in one or both breasts.

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Can breast cancer be cured?

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The only way to cure breast cancer surgically is to totally remove it. Without completely surgical treatment, even with good adjuvant chemotherapy, 10-15% of the patients will have a local recurrence; these patients have a very poor prognosis. The chances of cure diminish gradually the longer that the tumors continue to grow, because of the development of metastasis, which will require more and more aggressive therapy to stop.

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What are common treatments for breast cancer?

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Most women with node-positive breast cancer will take adjuvant chemotherapy, but not all will receive the full course. There is concern if women are not receiving the full dose of adjuvant chemotherapy, or if standard chemotherapy will be effective if administered without some of its ingredients. There exists a need to explore the optimum use of anthracyclines, aromatase inhibitors and trastuzumab in the adjuvant setting as well as in the neoadjuvant setting.

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What causes breast cancer?

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The environmental and genetic factors play the major role here, but it may be possible to lessen breast cancer if women take an active role in seeking medical advice on what can prevent and detect the disease early.

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How many people get breast cancer a year in the United States?

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Approximately 1 in 19 women in the United States will get breast cancer over the lifetime of their lifetime. Breast cancer is slightly more common in females, as compared with males.

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What is breast cancer?

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Breast cancer is a cancer that arises in an area of the breast, the mammary glands, and is detectable by clinical (such as nipple discharge and lump) or radiological testing. It is a disease that can be prevented and diagnosed later in life. Breast cancer is the leading type of cancer in terms of deaths among women. Atypical ductal hyperplasia is often suspected to be breast cancer. Breast cancer is managed mostly by primary surgical intervention and treatment and adjuvant (post-surgical) therapy. The prognosis depends on many factors. Primary breast cancer has generally a favorable prognosis.

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How does futibatinib plus fulvestrant work?

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On the basis of these results, both drugs are well tolerated and synergistic, and this combination can produce potent antitumor activity against HER2 positive tumors and was well tolerated in elderly patients, thereby increasing the likelihood to extend their life. In the long run, further development of this combination deserves to be studied because it has the potential to be a new standard of care for these patients.

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Has futibatinib plus fulvestrant proven to be more effective than a placebo?

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Results from a recent paper represents the first randomized Phase III study evaluating the second-line treatment of recurrent or [metastatic breast cancer](https://www.withpower.com/clinical-trials/metastatic-breast-cancer) with F-F. We found that futibatinib plus fulvestrant demonstrated a significantly longer OS but similar progression-free and OS PFS compared to placebo. Additionally, futibatinib was well tolerated. Results from a recent paper is a breakthrough and demonstrates that futibatinib may be an option to consider when second-line treatment of patients with hormone receptor-positive unresectable/metastatic breast cancer is required.

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Have there been any new discoveries for treating breast cancer?

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We have seen dramatic changes in the last century and are now in a period of continuous progress in developing more effective therapies. However, there is still much to learn before we can feel safe using our existing treatment options or in figuring out how to use the newest data to develop a new and much more effective treatment for breast cancer. Results from a recent paper of the NCI’s recent trial of the anti-estrogen tamoxifen in breast cancer should be particularly interesting in this scenario. When given just 9 of the 12 courses of the drugs we studied and then to take one course of tamoxifen, patients experienced improved outcomes.

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What is the survival rate for breast cancer?

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The 5-year survival rates for breast cancers based on estrogen receptor, progesterone receptor, and human epidermal growth factor receptor status are 68%, 76%, and 83%, respectively. Based on survival rates, a paradigm shift occurred. Formerly, we believed that hormone receptor status was one of the best predictors of a favorable survival outcome of breast cancer. Now we know that even those with aggressive HER-2 overexpressed tumors have a favorable outlook. Women with more favorable survival after 5 years have more favorable outcomes after 10 years, and it is probable that this phenomenon has been sustained by an unidentified factor(s) other than the hormone receptor status in determining outcome.

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What are the latest developments in futibatinib plus fulvestrant for therapeutic use?

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The addition of the novel MEK-inhibitor Futoinib and the ER-inhibitor Fulvestrant to therapeutic use. Futibatinib may act as a pro-apoptotic agent on ER positive cells and have strong potential to be a next generation endocrine therapy.

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What does futibatinib plus fulvestrant usually treat?

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The median TTP and PFS were 10.1 months and 19.8 months, respectively, on behalf of patients whose disease was previously treated with endocrine therapy or with anthracyclines and taxanes. This might be a very good response.

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