NCT03633331|CompletedPhase 2ResultsFDA Drug

Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer

A Phase II Trial Assessing the Tolerability of Palbociclib in Combination With Letrozole or Fulvestrant in Patients Aged 70 and Older With Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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2 other identifiers

A171601NCI-2017-01596

Study Type

interventional

Target

Locations

1 country

Sites

447

Timeline

RegisteredAug 2018

StartedAug 2018

CompletionFeb 2026

Brief Summary

This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to other places in the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as letrozole or fulvestrant, 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 palbociclib and letrozole or fulvestrant may work better in treating patients with breast cancer. The trial will explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Aug 2018

Longer than P75 for phase_2

Geographic Reach

1 country

447 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.5 years study duration

First Submitted

Initial submission to the registry

August 7, 2018

Completed

8 days until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2020

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

October 15, 2021

Completed

4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2026

Completed

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

August 7, 2018

Results QC Date

September 17, 2021

Last Update Submit

April 9, 2026

Conditions

Estrogen Receptor-positive Breast Cancer HER2/Neu Negative Stage IV Breast Cancer AJCC v6 and v7

Outcome Measures

Primary Outcomes (1)

Incidence of Adverse Events
Defined as the proportion of patients with documentation of grade 3 - 5 toxicity (regardless of attribution using the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v.\] 5.0 criteria). A 95% binomial confidence interval for single proportions will be constructed for the severe toxicity rate during treatment. Univariate relationships between the primary endpoint and various pre-treatment patient characteristics such as anemia, self-assessed functional status, or social support will be described via cross-tabulation and Fisher's exact testing. Exploratory logistic regression modeling, with limited generalizability due to the modest sample size, will be used to assess the relative contributions of these variables impact the likelihood of developing a severe toxicity during treatment. The strength of this association will be expressed in terms of an odds ratio and its associated 95% confidence interval.
6 months

Secondary Outcomes (10)

Commonality of Grade 3+ Drug Toxicities
1 year
Dose Reduction, Dose Hold, and Hospitalization Reasons
Up to 1 year
Time to Treatment Failure (and Reason for Coming Off Study - Toxicity, Patient Preference, Progression)
Up to 5 years
Palbociclib Adherence Rate
Up to 12 weeks
Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST)
Up to 1 year
+5 more secondary outcomes

Study Arms (1)

Treatment (palbociclib, letrozole or fulvestrant)

EXPERIMENTAL

Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: PalbociclibDrug: LetrozoleDrug: FulvestrantOther: Questionnaire AdministrationOther: Quality-of-Life Assessment

Interventions

PalbociclibDRUG

Given PO

Treatment (palbociclib, letrozole or fulvestrant)

LetrozoleDRUG

Given PO

Treatment (palbociclib, letrozole or fulvestrant)

FulvestrantDRUG

Given IM

Treatment (palbociclib, letrozole or fulvestrant)

Questionnaire AdministrationOTHER

Ancillary studies

Treatment (palbociclib, letrozole or fulvestrant)

Quality-of-Life AssessmentOTHER

Ancillary studies

Treatment (palbociclib, letrozole or fulvestrant)

Eligibility Criteria

Age70 Years+

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

You may qualify if:

Documentation of disease: estrogen receptor positive and/or progesterone receptor (PR) positive, HER2 negative metastatic breast cancer; histologic confirmation is required
Measurable disease or non-measurable disease
Planning to begin palbociclib for metastatic disease; one prior line of endocrine therapy and/or chemotherapy for metastatic disease is allowed; patients may begin or have already begun endocrine therapy before they start palbociclib treatment, but no more than two weeks prior to registration
No prior therapy with a CDK inhibitor
Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE grade =\< 1 (except alopecia) or to baseline toxicities prior to previous therapy or surgical procedures, prior to registration
No untreated brain metastases; patients with treated brain metastases must have completed treatment with steroids to be eligible
No known interstitial lung disease
No second malignancies other than non-melanoma skin cancers or cervical carcinoma in situ; however, patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for \>= 3 years
No active infection requiring treatment with antibiotics
Patients must be able to swallow and retain oral medication
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Patients must be able to read and comprehend English or Spanish
Absolute neutrophil count (ANC) \>= 1500/mm\^3 (1.5 x 10\^9/L)
Platelet count \>= 100,000/mm\^3 (100 x 10\^9/L)
Creatinine clearance \>= 30 ml/min calculated using the Cockcroft-Gault formula
+3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (447)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC