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

  • STATUS
    Recruiting
  • End date
    Dec 26, 2021
  • participants needed
    40
  • sponsor
    Shannon Puhalla
Updated on 17 March 2021
measurable disease
carcinoma
breast cancer
endocrine therapy
kidney function tests
metastasis
hormone therapy
brain metastases
bone metastases
aptt
tamoxifen
fulvestrant
aromatase inhibitor
palbociclib
immunological adjuvant

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

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.

Details
Condition Metastatic Breast Cancer, Stage IV Breast Cancer
Treatment tamoxifen, fulvestrant, Palbociclib
Clinical Study IdentifierNCT02913430
SponsorShannon Puhalla
Last Modified on17 March 2021

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