Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib
- Conditions
- Metastatic Breast Cancer
- Interventions
- Registration Number
- NCT02913430
- Lead Sponsor
- Shannon Puhalla
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 7
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Fulvestrant fulvestrant administered 500mg IM Q28 days plus palbociclib125mg/day PO on a 21 days on/7 days off schedule Arm A Palbociclib fulvestrant administered 500mg IM Q28 days plus palbociclib125mg/day PO on a 21 days on/7 days off schedule Arm B Tamoxifen Tamoxifen is administered orally, at a dose of20mg PO Qdaily plus palbociclib125mg/day PO on a 21 days on/7 days off schedule Arm B Palbociclib Tamoxifen is administered orally, at a dose of20mg PO Qdaily plus palbociclib125mg/day PO on a 21 days on/7 days off schedule
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) Up to 3 years and 351 days The duration of time from time of randomization to time of progression or death, whichever occurs first. Disease progression (PD) as defined by RECIST v1.1: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The progression of non-target lesions or the appearance of one or more new lesions is also considered progression.
PFS for a subject without an event will be censored on the date of last tumor assessment. If an interval of 6 months passes without a tumor assessment, PFS will be censored at the time of the earlier tumor assessment, even if an event (progressive disease or death) is later observed.
- Secondary Outcome Measures
Name Time Method Best Overall Response (BOR) Up to 5 years The number of patients experiencing Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) per RECIST v1.1; Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): (CR) is disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm; (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; (SD) is neither sufficient decrease (target lesions) to qualify as a PR or sufficient increase to qualify as PD. Incomplete Response/Stable Disease (SD) is the persistence of one or more non-target lesions. (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions. It also includes the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
6-Month Clinical Benefit Rate (CBR) Up to 6 months The number of patients experiencing Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1; Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): (CR) is disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm; (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; (SD) is neither sufficient decrease (target lesions) to qualify as a PR or sufficient increase to qualify as PD. Incomplete Response/Stable Disease (SD) is the persistence of one or more non-target lesions.
Clinical Benefit Rate (CBR) Up to 5 years The number of patients experiencing Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1; Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): (CR) is disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm; (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; (SD) is neither sufficient decrease (target lesions) to qualify as a PR or sufficient increase to qualify as PD. Incomplete Response/Stable Disease (SD) is the persistence of one or more non-target lesions.
Overall Survival (OS) Up to 5 years The median length of time from the start of treatment that patients remain alive.
Trial Locations
- Locations (1)
Magee-Womens Hospital UPMC
🇺🇸Pittsburgh, Pennsylvania, United States