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Hormone Therapy

Hormone + HER2-targeted Therapy for Breast Cancer (ADEPT Trial)

Phase 2

Recruiting

Led By Adrienne C Waks, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Patients who have undergone definitive breast surgery for the current malignancy

Patients with T1aN0, ER+ (≥ 10%), HER2-negative cancer in either breast, in addition to their primary HER2 positive tumor

Must not have

Pregnant women, nursing women, and women of childbearing potential unwilling to employ adequate contraception

Patients with a history of previous invasive breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of HER2-directed therapies and hormonal therapy as a treatment after surgery for hormone receptor positive breast cancer.

Who is the study for?

This trial is for adults with early-stage hormone receptor-positive, HER2-positive breast cancer who've had surgery. It's open to those who may have received short-term pre-surgery treatment or up to 8 weeks of hormonal therapy post-surgery. Participants must be willing to stop contraceptive hormones and provide tissue samples. Excluded are pregnant/nursing women, those with severe illnesses, previous invasive breast cancers, or anyone on other investigational drugs.

What is being tested?

The study tests a combination of trastuzumab and pertuzumab (PHESGO) injections plus hormonal therapy as post-surgical treatment for specific breast cancer patients. The goal is to evaluate the effectiveness of this combined HER2-directed and endocrine therapy in preventing cancer recurrence.

What are the potential side effects?

Potential side effects include reactions at the injection site, fatigue, nausea, diarrhea, heart issues related to trastuzumab and pertuzumab; hormonal therapy might cause hot flashes, mood swings, joint pain and increase risk of blood clots.

Eligibility Criteria

Inclusion Criteria

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

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I have had surgery for my current breast cancer.

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I have a small, ER+ (≥ 10%), HER2-negative tumor in addition to my primary HER2 positive tumor.

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Both of my breasts have cancers that qualify for the trial.

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I am fully active or can carry out light work.

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My organs and bone marrow are functioning normally.

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My breast cancer is HER2-positive, early stage, and has not spread to lymph nodes or only has tiny spread.

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I had DCIS on the same side and haven't had hormone therapy.

Exclusion Criteria

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

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I am not pregnant, nursing, or if capable of becoming pregnant, I am willing to use contraception.

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I have had breast cancer before.

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I am a man not willing to use birth control.

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I have not received chemotherapy before or after surgery for this breast cancer.

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I do not have any major health issues that would prevent me from following the study's requirements.

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My cancer was advanced but localized when diagnosed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 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

Invasive Disease Free Survival at 3 Years

Secondary study objectives

Breast cancer-specific survival (BCSS) at 10 Years

Breast cancer-specific survival (BCSS) at 3 Years

Breast cancer-specific survival (BCSS) at 7 Years

+8 more

Other study objectives

COST-Financial Toxicity

FACT B

Patient Acceptance of subcutaneous therapy (HPASQ-SC)

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: PERTUZUMAB + TRASTUZUMAB + ADJUVANT ENDOCRINE THERAPYExperimental Treatment2 Interventions

Study treatment will be administered in 21-day (3- week, +/- 3 days) cycles for one year (18 cycles). * Trastuzumab + Pertuzumab SC fixed dose combination * Hormonal therapy- oral, daily per cycle (may add LHRH agonist per investigator discretion)

0 / 13Eligibility criteria met