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Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib | Clinical Trials | Clareo Health

COMPLETEDEARLY_PHASE1

Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib

Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib: A Randomized Pilot Trial With ESR1 Mutation Tested in Circulating Tumor DNA.

NCT02913430•Shannon Puhalla

View on ClinicalTrials.gov

Summary

To assess longitudinal changes in allele frequency of ESR1 mutation in plasma in patients treated with Fulvestrant plus palbociclib compared to tamoxifen plus palbociclib

Detailed Description

The primary objectives are to assess longitudinal changes in allele frequency of ESR1 mutation in plasma in patients treated with Fulvestrant plus palbociclib compared to tamoxifen plus palbociclib. Patients with ER+ breast cancer who had 1 to 3 prior lines of endocrine therapy and up to one line of chemotherapy for MBC, excluding fulvestrant and tamoxifen, will be randomized in a 1:1 ratio to receive fulvestrant 500mg IM Q28 days with one extra dose on Day15 of the first cycle (as a loading dose) plus palbociclib 125mg/day PO on a 21 days on/7 days off schedule or tamoxifen 20mg PO daily plus palbociclib 125mg/day PO on a 21 days on/7 days off schedule.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For inclusion in the study subjects should fulfill the following criteria:
•1. Signed informed consent
•2. Patients must have histologically or cytologically confirmed invasive breast cancer that is ER+ (\>1% staining) with radiographical or clinical evidence of metastatic disease
•a. Measurable and/or non-measurable disease
•3. Prior therapies:
•1. Patients must have previously received an aromatase inhibitor in the adjuvant, neo-adjuvant or metastatic setting.
•2. Patients must have previously received palbociclib in the adjuvant, neo- adjuvant or metastatic setting. If patient is currently taking palbociclib at time of screening for the trial they may continue taking palbociclib.
•3. The minimum duration of AI in the adjuvant setting is 2 years.
•4. There is no minimum duration of AI in the metastatic setting or neoadjuvant setting.
•5. Patients may have been previously treated with an mTOR inhibitor or other investigational agent in addition to an aromatase inhibitor.
+18 more criteria

Exclusion Criteria

•1. Prior therapy exclusions:
•1. Prior therapy with fulvestrant
•2. Prior therapy with tamoxifen in the metastatic setting
•3. More than 3 prior lines of endocrine therapy in the metastatic setting
•4. More than one prior line of chemotherapy in the metastatic setting
•2. Washout of 2 weeks is required for aromatase inhibitors; washout of 4 weeks is required for, everolimus or other biological agents with the exception of Palbociclib.
•3. Patients must not be receiving any other investigational agent.
•5. Patients may not have significant concurrent illness, infection, pregnancy or lactation
•6. Patients must not have a different active malignancy, except for skin basal cell carcinoma, skin squamous cell carcinoma and cervical intraepithelial neoplasia.

Locations (1)

Magee-Womens Hospital UPMC

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

April 24, 2018

Primary Completion Date

April 12, 2022

Completion Date

April 30, 2024

Last Updated

September 23, 2024

Enrollment

ACTUAL participants

Conditions

Metastatic Breast Cancer

Interventions

Fulvestrant

DRUG

Tamoxifen

DRUG

Palbociclib

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGPHASE2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

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