PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA) (PALMIRA)

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    198
  • sponsor
    MedSIR
Updated on 30 April 2022
measurable disease
growth factor
endocrine therapy
progesterone
hormone therapy
advanced breast cancer
immunohistochemistry
epidermal growth factor receptor
HER2
EGFR
human epidermal growth factor
cancer treatment
gonadotropin releasing hormone
tamoxifen
estradiol
cancer therapy
progesterone receptor
fulvestrant
erbb2
epidermal growth factor
aromatase inhibitor
lhrh analogue
gnrh
palbociclib
liquid biopsy
letrozole
immunostimulant
mammogram

Summary

Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)

Description

Pre- and post-menopausal women age ≥ 18 years with HR-positive and HER2-negative with ABC that had previously received first-line endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib-based treatment. Patients relapsing on a palbociclib-based regimen in the adjuvant setting are also eligible. Patients are not eligible if they are candidates for a local treatment with a curative intention. Evidence of either measurable and biopsiable metastatic disease (as for Response Evaluation Criteria In Solid Tumors (RECIST v.1.1)) or non-measurable disease with bone lesion is required. Pre-menopausal women must be under treatment with luteinizing hormone-releasing hormone (LHRH) analogues.

Details
Condition Breast Cancer, Advanced Breast Cancer, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Treatment Palbociclib, Endocrine Therapy
Clinical Study IdentifierNCT03809988
SponsorMedSIR
Last Modified on30 April 2022

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