Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer

Summary

This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to see how they work compared to docetaxel, carboplatin, trastuzumab, and pertuzumab without estrogen deprivation in treating patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer that is operable or has spread from where it started to nearby tissue or lymph nodes (locally advanced). Drugs used in chemotherapy, such as docetaxel, carboplatin, trastuzumab, and pertuzumab, 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Estrogen can cause the growth of breast cancer cells. Hormone therapy using goserelin acetate and aromatase inhibition therapy may fight breast cancer by blocking the use of estrogen by the tumor cells. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy and radiation therapy with or without hormone therapy may be an effective treatment for hormone receptor-positive, HER2-positive, operable or locally advanced breast cancer.

Conditions

• HER2-Positive Breast Carcinoma
• Hormone Receptor-Positive Breast Carcinoma
• Stage IB Breast Cancer AJCC v7
• Stage IIA Breast Cancer AJCC v6 and v7
• Stage IIB Breast Cancer AJCC v6 and v7
• Stage IIIA Breast Cancer AJCC v7
• Stage IIIB Breast Cancer AJCC v7
• Stage IIIC Breast Cancer AJCC v7

Interventions

DRUG

Aromatase Inhibition Therapy

Given at the investigator's discretion

DRUG

Carboplatin

Given IV

OTHER

Cytology Specimen Collection Procedure

Undergo 2 core biopsies

DRUG

Docetaxel

Given IV

DRUG

Goserelin Acetate

Given SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Pertuzumab

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

PROCEDURE

Therapeutic Conventional Surgery

Undergo lumpectomy or mastectomy

BIOLOGICAL

Trastuzumab

Given IV

RADIATION

Whole Breast Irradiation

Undergo whole breast irradiation

Sponsors & Collaborators

• NRG Oncology

  collaborator OTHER

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Mothaffar F Rimawi · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-18

Primary Completion

2016-10-31

Completion

2025-06-30

Countries

• United States
• Puerto Rico

Study Locations