Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer

Summary

The investigators propose to influence estrogen receptor (ER) signaling by combining endocrine therapy with CDK4/6 inhibition along with trastuzumab in ER+/ human epidermal growth factor receptor 2 (HER2)+ early stage breast cancer.

Conditions

• Breast Cancer
• Cancer of Breast
• Breast Carcinoma

Interventions

DRUG

Palbociclib

Palbociclib is an oral drug given at a dose of 125 mg daily on Days 1-21 of each 28-day cycle for a total of 4 cycles.

DRUG

Letrozole

Letrozole is an oral drug given at a dose of 2.5 mg orally once a day. It will be taken continuously (Days 1-28 of each cycle) until the day of definitive surgery.

BIOLOGICAL

Trastuzumab

* Or FDA approved biosimilar * Trastuzumab will be administered on a weekly basis for 16 weeks (on Days 1, 8, 15, and 22 of each 28-day cycle for a total of 4 cycles). The first dose of trastuzumab on Cycle 1 Day 1 will be a loading dose of 4 mg/kg IVPB over 90 minutes. Subsequent doses of trastuzumab will be 2 mg/kg IVPB over 30 minutes. Weekly trastuzumab will continue after the completion of Cycle 4 of palbociclib until surgery.

DRUG

Goserelin

Goserelin is given subcutaneously at a dose of 3.6 mg on Day 1 of each cycle. Goserelin will be continued (once every 28-days) after the completion of Cycle 4 of palbociclib if required.

PROCEDURE

Breast surgery

Standard of care

PROCEDURE

Research tumor biopsy

Baseline, cycle 1 day 15, and surgery

PROCEDURE

Research bone marrow (OPTIONAL)

Baseline and surgery

PROCEDURE

Research blood sample

Baseline, cycle 1 day 15, surgery, and yearly post-surgery for 5 years

GENETIC

Research blood for germline DNA

Baseline

PROCEDURE

Blood for detection of circulating tumor cells

Baseline

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• Rising Tide Foundation

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Foluso O Ademuyiwa, M.D, MPH · Washington University School of Medicine

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-30

Primary Completion

2020-08-24

Completion

2020-09-23

FDA Drug

Yes

Countries

• United States

Study Locations