NCT02907918

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

A Phase II Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab as Neoadjuvant Treatment of Stage II-III ER+ HER2+ Breast Cancer (PALTAN)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-06-30
• Primary completion: 2020-08-24
• Completion: 2020-09-23
• First posted: 2016-09-20
• Last updated: 2021-09-29
• Results posted: 2021-09-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study