RecruitingPhase 2NCT04993014

Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer

Circulating Tumor Cells and Adjuvant Treatment De-escalation After Neoadjuvant Therapy With Trastuzumab and Pertuzumab for HER2 Positive Early Breast Cancer


Sponsor

AC Camargo Cancer Center

Enrollment

80 participants

Start Date

Mar 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Phase II unicentric randomized trial which will include early HER2 positive breast cancer patients, candidate to neoadjuvant therapy with trastuzumab and pertuzumab. Circulating tumor cells will be collected at neoadjuvant therapy baseline. Patients with pathological complete response will be randomized in 1:1 ratio for adjuvant trastuzumab (arm A) versus trastuzumab + pertuzumab (arm B) in a two factorial design: group A, with HER2 positive CTCs and group B, with HER2 negative/absent CTCs.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether patients with HER2-positive breast cancer who have a complete response to pre-surgery chemotherapy (no cancer cells found after surgery) can safely skip additional chemotherapy after surgery, using circulating tumor cells (cancer cells found in the blood) as a guide. **You may be eligible if...** - You have HER2-positive breast cancer (hormone receptor positive or negative) - Your cancer is stage I–III - You are receiving pre-surgery chemotherapy plus trastuzumab and pertuzumab - You had surgery after neoadjuvant therapy and achieved a complete pathological response (no remaining cancer) - You are in good overall health (ECOG 0–3) **You may NOT be eligible if...** - You have a contraindication to trastuzumab or pertuzumab - You are receiving adjuvant chemotherapy (hormone therapy is allowed) - You have been diagnosed with a second primary cancer in the last 5 years (except treated non-melanoma skin cancer or in-situ cervical cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPertuzumab

Adjuvant trastuzumab + pertuzumab (arm B of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline)

DRUGTrastuzumab

Adjuvant trastuzumab (arm A of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline) Association with pertuzumab in arm B of the 2 cohorts

OTHERCirculating tumor cells

Blood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done.


Locations(1)

A.C. Camargo Cancer Center

São Paulo, Brazil

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NCT04993014


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