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Hormone Therapy

Hormone Therapy + Chemotherapy for Breast Cancer

Phase 3

Waitlist Available

Led By Kevin M Kalinsky

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

Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2 status

Patients must have had either breast-conserving surgery with planned radiation therapy or total mastectomy

Must not have

Patients must not require chronic treatment with systemic steroids or other immunosuppressive agents

Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization to a maximum of 5.5 years or death

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing 4 different hormone therapies with or without chemotherapy to see which is most effective in treating patients with invasive breast cancer.

Who is the study for?

This trial is for women aged 18+ who've had breast surgery and need radiation or mastectomy, with a performance status of 0-2. They must be able to receive certain chemotherapies, have node-positive invasive breast cancer that's estrogen/progesterone receptor positive and HER-2 negative. No recent other cancers (except some skin/cervical cancers) or chronic steroid/immunosuppressant use.

What is being tested?

The study compares the effectiveness of hormone therapies (tamoxifen citrate, anastrozole, letrozole, exemestane) alone versus combined with chemotherapy in treating invasive breast cancer. It aims to see which combination better stops tumor growth by blocking estrogen or killing/dividing cells.

What are the potential side effects?

Possible side effects include hot flashes, mood swings, joint pain from hormone therapy; nausea, hair loss, fatigue from chemotherapy. Each patient may experience side effects differently depending on their individual response to treatment.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is hormone receptor positive, HER2 negative, and has spread to 1-3 lymph nodes.

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I had surgery for breast cancer and will have or had radiation.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I am a woman and I am 18 years old or older.

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I can receive chemotherapy that includes taxane or anthracycline.

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I have had a procedure to check for cancer in my underarm lymph nodes.

Exclusion Criteria

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

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I am not on long-term steroids or drugs that weaken my immune system.

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I have not started any chemotherapy or hormone therapy for my breast cancer.

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I do not have inflammatory breast cancer or cancer that has spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization to a maximum of 5.5 years or death

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization to a maximum of 5.5 years or death

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization to a maximum of 5.5 years or death for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Invasive Disease-Free Survival (IDFS)

Secondary study objectives

Distant Disease-Free Survival (DDFS)

Local Disease-Free Interval (LDFI)

Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

+3 more

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

Group I: Arm II (endocrine therapy)Experimental Treatment6 Interventions

Patients receive a protocol-approved endocrine therapy comprising tamoxifen citrate, an aromatase inhibitor (anastrozole, letrozole, or exemestane), or both for 5-10 years in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (chemotherapy and endocrine therapy)Experimental Treatment7 Interventions

Patients receive a protocol-approved chemotherapy regimen based on the patient and/or physician preference. Patients then receive a protocol-approved adjuvant endocrine therapy comprising tamoxifen citrate, an aromatase inhibitor (anastrozole, letrozole, or exemestane), or both for 5-10 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exemestane

2003

Completed Phase 4

~7510

Tamoxifen Citrate

2011

Completed Phase 3

~3880