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Hormone Therapy

Fulvestrant + Anastrozole for Breast Cancer

Phase 3

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Postmenopausal, verified by: post bilateral surgical oophorectomy or no spontaneous menses ≥ 1 year or no menses for < 1 year with follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards

Must not have

Premenopausal status

Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing whether neoadjuvant endocrine therapy with fulvestrant or the combination of anastrozole and fulvestrant is better than anastrozole when given before surgery to shrink the cancer and stop it from growing.

Who is the study for?

Postmenopausal women with Stage II-III estrogen receptor positive breast cancer, who have not started any treatment and are planning to undergo surgery. Participants must be at least 18 years old, have a specific score indicating the presence of estrogen receptors in their tumor cells, and meet certain health criteria based on blood tests and physical exams.

What is being tested?

The trial is testing whether taking fulvestrant alone or combined with anastrozole before surgery is more effective than just anastrozole for shrinking tumors. Anastrozole lowers estrogen to inhibit tumor growth and is standard care pre-surgery; fulvestrant decreases estrogen receptors in tumor cells but isn't approved for early-stage use yet.

What are the potential side effects?

Possible side effects include hot flashes, joint pain, nausea, fatigue, bone weakness or loss (osteoporosis), mood changes, vaginal dryness or bleeding. Fulvestrant may also cause injection site reactions such as pain or inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform daily activities.

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I am postmenopausal, confirmed by surgery, lack of periods for a year or hormone levels.

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My breast cancer is at a stage where surgery is aimed to remove the tumor and it can be felt or measured to be at least 2cm.

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My breast cancer was confirmed with a needle biopsy.

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I am a woman aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not gone through menopause.

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My breast cancer involves redness of the breast or skin invasion.

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I have had a surgical biopsy for my breast cancer.

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My tumor is either low in estrogen receptors or HER2 positive.

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I have not received any treatment for my cancer before joining this study.

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I have had invasive breast cancer or cancer in the opposite breast.

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I have not taken hormone replacement therapy or similar medications in the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Arm III (anastrozole and fulvestrant)Active Control2 Interventions

Patients receive anastrozole daily in combination with fulvestrant on days 1 and 15 of cycle 1, and on day 1 of cycles 2-6 followed by surgery. A treatment cycle is 4 weeks in length. After completion of analysis of endocrine resistant data, patients will continue treatment as defined in the protocol.

Group II: Arm I (anastrozole)Active Control1 Intervention

Patients receive anastrozole daily for 6 cycles followed by surgery. A treatment cycle is 4 weeks in length. After completion of analysis of endocrine resistant data, patients will continue treatment as defined in the protocol.

Group III: Arm II (fulvestrant)Active Control1 Intervention

Patients receive fulvestrant on days 1 and 15 of cycle 1 and day 1 of cycles 2-6 followed by surgery. A treatment cycle is 4 weeks in length. After completion of analysis of endocrine resistant data, patients will continue treatment as defined in the protocol.

0 / 12Eligibility criteria met