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To assess longitudinal changes in allele frequency of ESR1 mutation in plasma in patients treated with Fulvestrant plus palbociclib compared to tamoxifen plus palbociclib
Full 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.
Enrollment
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Inclusion and exclusion criteria
For inclusion in the study subjects should fulfill the following criteria:
Signed informed consent
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
Prior therapies:
Brain metastasis is allowed if previously treated, stable and off steroids for a minimum of 56 days
Age > 18 years
Male or female breast cancer is allowed
Patients may be pre- or post-menopausal; pre-menopausal patients must be on ovarian suppression and must be adequately suppressed on LHRH agonists with estradiol levels in the post-menopausal range
a. Premenopausal patients cannot be pregnant and must agree to adequate birth control in addition to ovarian suppression. Agreement by the patient and/or partner to use highly effective, nonhormonal form of contraception or two effective forms of non-hormonal contraception. Contraception use should continue during the duration of study treatment and for at least 6 months after the last dose of study treatment.
ECOG performance status 0-2
Adequate bone marrow function as indicated by the following, within 14 days of enrollment:
Adequate liver function, as indicated by the following, within 14 days of enrollment.
Adequate hemostatic function as determined by PT, INR and aPTT < 1.5× ULN (unless on therapeutic coagulation, in which case the adequate level of anticoagulation will be determined by the investigator).
Adequate renal function, as indicated by creatinine ≤ 1.5 ULN.
Subjects should not enter the study if any of the following exclusion criteria are fulfilled
Prior therapy exclusions:
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.
Patients must not be receiving any other investigational agent.
Patients with symptomatic, untreated CNS metastases are not eligible.
Patients may not have significant concurrent illness, infection, pregnancy or lactation
Patients must not have a different active malignancy, except for skin basal cell carcinoma, skin squamous cell carcinoma and cervical intraepithelial neoplasia.
Primary purpose
Allocation
Interventional model
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7 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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