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Hormone Therapy

Hormone Therapy + Immunotherapy for Advanced Breast Cancer

Phase 3

Waitlist Available

Led By Hope S Rugo

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Histologic confirmation of invasive cancer of the female breast in either the primary or metastatic setting

Tumors must express estrogen receptor (ER) and/or progesterone receptor (PgR) in >= 1% of cells

Must not have

Currently active second malignancy other than non-melanoma skin cancers

Anticipation of need for major surgical procedure during the course of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing tamoxifen citrate or letrozole with or without bevacizumab to treat stage IIIB or IV breast cancer. Estrogen fuels breast cancer cell growth, so hormone therapy with tamoxifen or letrozole can block estrogen and stop tumor growth. Bevacizumab is an immunotherapy that may help the body's immune system fight the cancer. Researchers want to see if it is more effective with or without bevacizumab.

Who is the study for?

This trial is for postmenopausal women or premenopausal women on ovarian suppression with stage IIIB or IV breast cancer that responds to hormones. Participants should not have had major surgery recently, no history of significant bleeding, fistulas, or abdominal abscesses, and no severe cardiovascular issues. They must have a life expectancy of at least 12 weeks and be in good physical condition (ECOG <=1).

What is being tested?

The study is testing the effectiveness of hormone therapies tamoxifen citrate or letrozole alone versus combined with the monoclonal antibody bevacizumab in advanced breast cancer. The goal is to see if adding bevacizumab improves outcomes by altering the immune system's response to tumor cells.

What are the potential side effects?

Bevacizumab can cause high blood pressure, increased risk of bleeding and blood clots, headaches, mouth sores, and proteinuria (excess protein in urine). Tamoxifen may lead to hot flashes, vaginal discharge or bleeding, and an increased risk of blood clots. Letrozole side effects include bone pain, cholesterol changes, fatigue.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer has been confirmed by tissue analysis.

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My tumor is positive for estrogen or progesterone receptors.

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I am a woman who has gone through menopause or am premenopausal with ovarian suppression.

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I don't expect to need any major surgery while in the study.

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I haven't had any major abdominal issues or bleeding recently.

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I have no allergies to AI or tamoxifen medications.

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I can carry out all my self-care but cannot do heavy physical work.

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I do not have any serious wounds, ulcers, or broken bones that are not healing.

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My kidney function test shows less than 1g of protein in my urine over 24 hours.

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I have never had a stroke, transient ischemic attack, or cancer spread to my brain.

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My cancer is at stage IV or inoperable stage IIIB.

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I do not have any major heart problems.

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I am not pregnant.

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My blood clotting time is normal or I'm on warfarin.

Exclusion Criteria

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

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I have another active cancer besides non-melanoma skin cancer.

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I expect to need a major surgery during the study.

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I am allergic to certain drugs used in AI or tamoxifen treatment.

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I need some help with my daily activities.

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I had a biopsy or minor surgery within the last week.

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I have not had serious abdominal issues or significant bleeding recently.

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I have a serious heart condition.

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I have had a stroke, a transient ischemic attack, or cancer that has spread to my brain.

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I am not postmenopausal and not undergoing ovarian suppression.

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I have been treated with anti-VEGF or VEGFR inhibitors before.

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I have a serious wound or fracture that is not healing.

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My INR is over 1.6 and I am not on full dose warfarin.

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

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival

Secondary study objectives

12 Month Progression Free Survival Rate

6 Month Progression-Free Survival Rate

Duration of Tumor Response

+4 more

Side effects data

From 2018 Phase 4 trial • 79 Patients • NCT02137538

10%

Fracture

Acne

Scoliosis

Hair loss

Sacroiliitis

Neuro event

100%

80%

60%

40%

20%

Study treatment Arm

Anastrozole

Letrozole

Awards & Highlights

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

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (endocrine therapy with monoclonal antibody)Experimental Treatment5 Interventions

Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (endocrine therapy)Active Control4 Interventions

Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Tamoxifen Citrate

2011

Completed Phase 3

~3780