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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

ADEPT Trial 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.Check my eligibility

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.See study design

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.

ADEPT Trial 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.

Select...

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

Select...

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.

Select...

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

ADEPT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Invasive Disease Free Survival at 3 Years

Secondary outcome measures

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 outcome measures

COST-Financial Toxicity

FACT B

Patient Acceptance of subcutaneous therapy (HPASQ-SC)

+6 more

ADEPT 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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,080 Previous Clinical Trials

340,562 Total Patients Enrolled

141 Trials studying Breast Cancer

22,245 Patients Enrolled for Breast Cancer

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

567,650 Total Patients Enrolled

96 Trials studying Breast Cancer

22,843 Patients Enrolled for Breast Cancer

Adrienne C Waks, MDPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

ADJUVANT ENDOCRINE THERAPY (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04569747 — Phase 2

Breast Cancer Research Study Groups: PERTUZUMAB + TRASTUZUMAB + ADJUVANT ENDOCRINE THERAPY

Breast Cancer Clinical Trial 2023: ADJUVANT ENDOCRINE THERAPY Highlights & Side Effects. Trial Name: NCT04569747 — Phase 2

ADJUVANT ENDOCRINE THERAPY (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04569747 — Phase 2

Frequently Asked Questions

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

Has the combined Pertuzumab+TRASTUZUMAB treatment achieved regulatory acceptance?

"Based on the current evidence, we have assigned a safety rating of 2 to Pertuzumab+TRASTUZUMAB as this is a Phase II trial which has provided some data that suggests it is safe but none regarding its efficacy."

Answered by AI

To what type of disorder is Pertuzumab+TRASTUZUMAB most frequently prescribed?

"Pertuzumab+TRASTUZUMAB is routinely used to treat inflammatory breast cancer (IBC) and can be prescribed to address several other ailments such as estrogen receptors, malignant neoplasms, or ovarian cancer."

Answered by AI

How many individuals are involved in this experiment?

"Affirmative. According to clinicaltrials.gov, this medical experiment is actively searching for participants and was posted on the 11th of January 2021 before being updated as recently as November 14 2022. It seeks 375 people from 18 different sites."

Answered by AI

How widespread is this research endeavor throughout the state?

"Potential participants can find a trial location at Dana-Farber Brigham Cancer Center - Foxborough in Foxboro, New york University Langone Hospital - Long Island in Mineola, and Dana-Farber at Milford in Milford. Additionally, there are 15 other sites currently offering this medication to patients."

Answered by AI

What evidence exists for the effectiveness of Pertuzumab+TRASTUZUMAB combinatory therapy?

"The combination of Pertuzumab and Trastuzumab was initially researched in 1994 at Queen Mary University of London. As of now, 973 trials have been concluded while 483 are still ongoing; many taking place around Foxboro, Massachusetts."

Answered by AI

Are there any openings for volunteers in this research endeavor?

"According to the information posted on clinicaltrials.gov, those interested in participating can do so as this trial is actively recruiting patients. It was initially made available on November 1st 2021 and has been revised most recently on November 14th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer

Adrienne G. Waks 2021. "A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04569747.

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