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Monoclonal Antibodies

Sequential Therapy for HER2+ Breast Cancer

Phase 2

Waitlist Available

Led By Heather Parsons, MD, MPH

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

Age ≥18 years

Patients must have stage IV breast carcinoma at diagnosis with unequivocal evidence of metastasis on imaging

Must not have

Medical history of myocardial infarction within 6 months before enrollment or symptomatic CHF

Major surgical procedure or significant traumatic injury within 28 days of study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a series of drugs to see if they are safe and effective for treating HER2+ Breast Cancer. The study will help researchers understand if giving intense treatment for a period and then stopping

Who is the study for?

This trial is for individuals with newly diagnosed HER2+ metastatic breast cancer. Participants should be suitable for a sequence of targeted therapies, but specific inclusion and exclusion criteria are not provided in the details given.

What is being tested?

The study tests a sequential treatment regimen using various drugs including Taxanes, Trastuzumab, Pertuzumab, Trastuzumab Deruxtecan, Tucatinib, and Ado-Trastuzumab Emtansine (T-DM1) to see if intensifying therapy initially then stopping is effective.

What are the potential side effects?

Potential side effects may include reactions related to anti-microtubule agents such as nerve damage or allergic reactions; monoclonal antibodies could cause infusion reactions; and HER2 inhibitors might lead to heart issues or diarrhea.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My breast cancer was stage IV at diagnosis with clear signs of spreading on scans.

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My organ and bone marrow functions meet the required levels.

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My breast cancer is advanced and cannot be removed by surgery.

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My breast cancer is HER2-positive and confirmed by tests on both breast and metastatic sites.

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I haven't had systemic therapy for breast cancer, except for THP within the last 6 weeks.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I had a heart attack in the last 6 months or have heart failure symptoms.

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I have not had major surgery or a serious injury in the last 28 days.

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I have had invasive breast cancer before.

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I have received radiotherapy for symptom relief outside the brain within the last week.

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I do not have untreated brain issues, uncontrolled seizures, serious heart problems, severe lung disease, active infections, trouble swallowing pills, ongoing severe diarrhea, and I'm not pregnant or breastfeeding.

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

Disease Free Survival at 4 Years (DFS4)

Secondary study objectives

Complete Rate of Each Treatment Part

DFS4 by Minimal Residual Disease (MRD) status

Grade 3-5 Treatment-Related Toxicity Rate

+3 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: HER2+ Breast CancerExperimental Treatment10 Interventions

Participants will complete: * Screening visit with tumor biopsy and imaging. * Imaging on Day I of cycles for Parts A through D. * Part A: * Day 1 of 21 day cycle: Predetermined dose of Trastuzumab (or biosimilar) 1X daily * Day 1 of 21 day cycle: Predetermined dose of Pertuzumab 1X daily * Predetermined dose of Taxane (Paclitaxel, Docetaxel, or Nab-Paclitaxel) * Part B: --Day 1 of 21 day cycle: Predetermined dose of trastuzumab deruxtecan 1X daily * Part C: * Day 1 of 21 day cycle: Predetermined dose of T-DM1 1X daily * Days 1 through 21 of 21 day cycle: Predetermined dose of Tucatinib 2X daily * Part D: * Imaging every 9 weeks * Days 1 through 21 of 21 day cycle: Predetermined dose of Tucatinib 2X daily * Day 1 of 21 day cycle: Predetermined dose of Trastuzumab (biosimilar or SC) 1X daily * Day 1 of 21 day cycle: Predetermined dose of Pertuzumab (or PHESGO) 1X daily * Follow Up: visits every 12 weeks with imaging every 9 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pertuzumab

2014

Completed Phase 3

~7500

Nab-Paclitaxel

2014

Completed Phase 3

~4540