CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy

Summary

This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.

Conditions

• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage IIA Breast Cancer AJCC v8
• Anatomic Stage IIB Breast Cancer AJCC v8
• Anatomic Stage IIIA Breast Cancer AJCC v8
• Invasive Breast Carcinoma
• Prognostic Stage II Breast Cancer AJCC v8
• Prognostic Stage IIA Breast Cancer AJCC v8
• Prognostic Stage IIB Breast Cancer AJCC v8
• Prognostic Stage IIIA Breast Cancer AJCC v8

Interventions

DRUG

Docetaxel

Given IV

PROCEDURE

Lumpectomy

Undergo lumpectomy

PROCEDURE

Mastectomy

Undergo mastectomy

DRUG

Nab-paclitaxel

Given IV

DRUG

Paclitaxel

Given IV

BIOLOGICAL

Pertuzumab

Given IV

RADIATION

Radiation Therapy

Undergo radiation therapy

BIOLOGICAL

Trastuzumab

Given IV

BIOLOGICAL

Trastuzumab Emtansine

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• ECOG-ACRIN Cancer Research Group

  lead NETWORK

Principal Investigators

• Nadine M Tung · ECOG-ACRIN Cancer Research Group

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-13

Primary Completion

2026-10-31

Completion

2038-12-31

Countries

• United States
• Puerto Rico

Study Locations