CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 315 enrolled
Drug / intervention
Aromatase Inhibition Therapy +10 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02003209
NCT02003209Phase 3Completed

A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients With Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated With Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) With or Without Estrogen Deprivation

National Cancer Institute (NCI)·interventional·Posted Dec 6, 2013·Updated Aug 8, 2025

In Brief

A Phase 3 clinical trial evaluating Aromatase Inhibition Therapy, Carboplatin, and 9 other interventions for HER2-Positive Breast Carcinoma and 7 related conditions. Completed, enrolled 315 participants across 732 sites in 2 countries.

Detailed 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.

Study Details

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 6, 2013
Enrollment StartFeb 18, 2014
Primary CompletionOct 31, 2016
Study CompletionJun 30, 2025
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 12.6 years ago

Interventions

Aromatase Inhibition Therapydrug

Given at the investigator's discretion

Carboplatindrug

Given IV

Cytology Specimen Collection Procedureother

Undergo 2 core biopsies

Docetaxeldrug

Given IV

Goserelin Acetatedrug

Given SC

Laboratory Biomarker Analysisother

Correlative studies

Pertuzumabbiological

Given IV

Quality-of-Life Assessmentother

Ancillary studies

Therapeutic Conventional Surgeryprocedure

Undergo lumpectomy or mastectomy

Trastuzumabbiological

Given IV

Whole Breast Irradiationradiation

Undergo whole breast irradiation