Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer (PALTAN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02907918|
Recruitment Status : Terminated (Futility)
First Posted : September 20, 2016
Results First Posted : September 5, 2021
Last Update Posted : September 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Cancer of Breast Breast Carcinoma||Drug: Palbociclib Drug: Letrozole Biological: Trastuzumab Drug: Goserelin Procedure: Breast surgery Procedure: Research tumor biopsy Procedure: Research bone marrow (OPTIONAL) Procedure: Research blood sample Genetic: Research blood for germline DNA Procedure: Blood for detection of circulating tumor cells||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||June 30, 2017|
|Actual Primary Completion Date :||August 24, 2020|
|Actual Study Completion Date :||September 23, 2020|
Experimental: Palbociclib + letrozole + trastuzumab +/- goserelin
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.
Other Name: Ibrance
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.
Other Name: Femara®
Other Name: Herceptin®
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.
Other Name: Zoladex
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
Procedure: Blood for detection of circulating tumor cells
- Number of Participants With Pathologic Complete Response (pCR) [ Time Frame: Completion of 4 cycles of treatment (approximately 16 weeks) ]A pathologic complete response (pCR) is defined as no histology evidence of invasive tumor cells in the surgical breast specimen and sentinel or axillary lymph nodes.
- Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events [ Time Frame: 30 days after completion of neoadjuvant therapy (approximately 21 weeks) ]-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
- Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE [ Time Frame: Baseline, cycle 2 day 1 (approximately 29 days), and end of cycle 4 (approximately 16 weeks) ]
- Answers ranging from None to Very Severe (none=0 to very severe=4); Not at All to Very Much (not at all=0 to very much=4), Never to Almost Constantly (0=never to almost constantly=4)
- PRO-CTCAE responses are scored from 0 to 4, and there are no standardized scoring rules yet established for how to combine attributes into a single score or how best to analyze PRO-CTCAE data longitudinally.
- PRO-CTCAE scores for each attribute (frequency, severity and/or interference) will be presented descriptively
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907918
|United States, Arizona|
|Phoenix, Arizona, United States, 85054|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Foluso O Ademuyiwa, M.D, MPH||Washington University School of Medicine|