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Monoclonal Antibodies

T-DM1 + Pertuzumab for Breast Cancer

Phase 2
Waitlist Available
Led By Ian Krop, MD, PhD
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
ECOG performance status 0 or 1
Patients must have HER2-positive Stage II or III histologically confirmed invasive carcinoma of the breast with a minimum tumor size of 2 cm determined by physical exam or imaging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-surgery follow-up of disease and survival occurs every 6 months for 5 years and annually until year 10.
Awards & highlights

Study Summary

This trial is studying T-DM1 in combination with pertuzumab to see how well it works compared with T-DM1 or pertuzumab alone in treating patients with breast cancer that has spread to other parts of the body and tests positive for HER2.

Who is the study for?
This trial is for men and women over 18 with early-stage HER2+ breast cancer, who are in good health (ECOG 0 or 1), can provide tissue samples, and agree to use contraception. Excluded are those with active infections, liver disease, pregnancy/nursing status, significant neuropathy symptoms, other serious diseases that could interfere with treatment, prior treatment for current breast cancer or recent IV antibiotics.Check my eligibility
What is being tested?
The study tests a combination of two drugs: Trastuzumab emtansine (T-DM1) and Pertuzumab as pre-operative treatments for HER2+ breast cancer. It aims to evaluate the effectiveness of this drug duo before surgical interventions like tumor excision or mastectomy.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to these drugs which may affect organs; fatigue; issues affecting blood cells leading to increased infection risk; possible impact on liver enzymes; and heart function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My breast cancer is HER2-positive, Stage II or III, and my tumor is at least 2 cm big.
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My cancer is HER-2 positive, confirmed by specific tests.
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My cancer's hormone receptor status has been tested.
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Both of my breast cancers are HER2 positive.
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I can safely receive radiation therapy for my breast cancer.
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I am a premenopausal woman and my pregnancy test is negative.
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I am not taking strong CYP3A4 inhibitor medications during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-surgery follow-up of disease and survival occurs every 6 months for 5 years and annually until year 10.
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-surgery follow-up of disease and survival occurs every 6 months for 5 years and annually until year 10. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Pathologic Complete Response (pCR) by HER2 Amplification Status Non-Heterogeneous
Secondary outcome measures
Clinical Response Rate (Complete Response)
Clinical Response Rate (Partial Response)
Hormone Receptor (HR) Status by HER2 Amplification Status
+5 more

Side effects data

From 2019 Phase 2 trial • 32 Patients • NCT02073487
69%
Liver Function Abnormality
50%
Fatigue
44%
Diarrhea
38%
Hypokalemia
19%
Neuropathy
19%
Rash
19%
Nausea
6%
Breast pain
6%
Musculoskeletal pain
6%
Hypomagnesemia
6%
Mucositis
6%
Depression
6%
Anxiety
6%
Chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab + Pertuzumab + Paclitaxel
T-DM1 + Lapatinib + Abraxane

Trial Design

1Treatment groups
Experimental Treatment
Group I: T-DM1 and PertuzumabExperimental Treatment3 Interventions
T-DM1 3.6 mg per kg of body weight via IV every 3 weeks for 6 doses and Pertuzumab loading dose of 840 mg via IV on Cycle 1 Day 1 followed by maintenance dose of 420 mg via IV every 3 weeks for 6 doses. Excision of tumor/mastectomy of biopsy residual tumor within 42 days of the last cycle of therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
T-DM1
2014
Completed Phase 2
~450
Pertuzumab
2014
Completed Phase 3
~7500

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,708 Total Patients Enrolled
141 Trials studying Breast Cancer
22,453 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,525 Total Patients Enrolled
96 Trials studying Breast Cancer
23,054 Patients Enrolled for Breast Cancer
Ian Krop, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
5 Previous Clinical Trials
336 Total Patients Enrolled
4 Trials studying Breast Cancer
256 Patients Enrolled for Breast Cancer

Media Library

Pertuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02326974 — Phase 2
Breast Cancer Research Study Groups: T-DM1 and Pertuzumab
Breast Cancer Clinical Trial 2023: Pertuzumab Highlights & Side Effects. Trial Name: NCT02326974 — Phase 2
Pertuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02326974 — Phase 2

Frequently Asked Questions

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

What are some of the most popular reasons why patients take T-DM1?

"T-DM1 can be used as a treatment for inflammatory breast cancer (ibc), malignant neoplasms, and non-small cell lung carcinoma."

Answered by AI

Has research like this been conducted before?

"T-DM1 has 119 ongoing clinical trials in 67 countries and 1721 cities. The first T-DM1 trial started in 2008 and was sponsored by Hoffmann-La Roche. That initial study had 720 participants and completed Phase 2 drug approval. Since then, 94 other trials have concluded."

Answered by AI

Are there any open vacancies for this clinical trial?

"The study in question, which was last updated on March 4th, 2022 and originally posted on January 1st, 2015, is not recruiting patients at this time. However, there are 2817 other clinical trials that are actively seeking candidates."

Answered by AI

Are there previous examples of T-DM1 being used in a medical setting?

"Currently, there are 119 T-DM1 clinical trials being conducted worldwide. 32 of those active studies are in their third stage of research. Most of the Wuhan, Other based studies for T-DM1 treatment. However, there are 11026 locations running these types of investigations."

Answered by AI

Can T-DM1 be legally administered to patients in the United States?

"T-DM1's safety is estimated to be a 2. This is because, while there is some evidence of its safety, there are no studies that support its efficacy."

Answered by AI

How many people are allowed to join this clinical trial?

"Though this study was posted over 2 years ago and updated less than a month ago, it is not currently looking for patients. However, there are 2698 trials related to breast cancer and 119 studies specifically on T-DM1 that are actively recruiting right now."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA
Otto Metzger, MD 2015. "T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02326974.
~16 spots leftby Apr 2025
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