Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Letrozole

Palbociclib

Goserelin

Antineoplastic Agents, Immunological

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Protein Kinase Inhibitors

Antineoplastic Agents, Hormonal

* Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles
* Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician

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.

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.

* 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.

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.

Breast surgery

Research tumor biopsy

Research bone marrow (OPTIONAL)

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

Research blood sample

Research blood for germline DNA

Blood for detection of circulating tumor cells

Foluso O Ademuyiwa, M.D, MPH

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.

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)

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.

-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.

* 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

Pfizer

Rising Tide Foundation

Washington University School of Medicine

Palbociclib + Letrozole + Trastuzumab +/- Goserelin

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Foluso O. Ademuyiwa, M.D., MPH

One participant is not evaluable for this outcome measure because the participant experienced progressive disease after completion of treatment but prior to surgery.

Number of Participants With Pathologic Complete Response (pCR)

Neutrophil count decreased

Lymphocyte count decreased

Hypertension

White blood cell decreased

Colitis

Hypokalemia

Pulmonary edema

Ventricular tachycardia

Alanine aminotransferase increased

Aspartate aminotransferase increased

Colonic obstruction

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

In the last 7 days, what was the severity of your decreased appetite at its worst?

In the last 7 days, how much did decreased appetite interfere with your usual or daily activities?

In the last 7 days, how often did you have nausea?

In the last 7 days, what was the severity of your nausea at its worst?

In the last 7 days, what was the severity of your shortness of breath (SOB) at its worst?

In the last 7 days, how much did your SOB interfere with your usual or daily activities?

In the last 7 days, what was the severity of your cough at its worst?

In the last 7 days, how much did your cough interfere with your usual and daily activities?

In the last 7 days, how often did you have arm or leg swelling?

In the last 7 days, what was the severity of your arm or leg swelling at its worst?

In the last 7 days, how much did arm or leg swelling interfere with your usual or daily activities?

In the last 7 days, how often did you feel a pounding or racing heartbeat (palpitations)?

In the last 7 days, what was the severity of your pounding or racing heartbeat at its worst?

In the last 7 days, did you have any rash?

In the last 7 days, what was the severity of your dry skin at its worst?

In the last 7 days, did you have any hair loss?

In the last 7 days, what was the severity of your problems with concentration at their worst?

In the past 7 days, how much did problems with concentration interfere with usual/daily activities?

Spots Global Cancer Trial Database for Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer

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