Statement: the secondary trial and the primary trial do not both use Clinical Benefit Rate as their outcome measure, and they do not use the same time frame.
Primary_evidence: Outcome Measurement:    Clinical Benefit Rate (CR + PR + SD > 6 Months).   To determine the clinical benefit rate (Complete Response + Partial Response + Stable Disease > 6 months) per Response Evaluation Criteria in Solid tumors (RECIST version 1.0). of MPA monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer. This will show the percent of patients who had Clinical Benefit and the Exact 95% Confidence Interval.   Time frame: baseline through end of study, up to 3 years Results 1:    Arm/Group Title: Cohort I: MPA-Alone   Arm/Group Description: Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.   Overall Number of Participants Analyzed: 14   Measure Type: Number   Unit of Measure: Percent of Participants  7.1        (0.2 to 33.9) Results 2:    Arm/Group Title: Cohort 2: MPA+IdoCM   Arm/Group Description: Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.   Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week.   Overall Number of Participants Analyzed: 16   Measure Type: Number   Unit of Measure: Percent of Participants  6.3        (0.2 to 30.2)
Secondary_evidence: Outcome Measurement:    Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Mutant Cohort   Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.   Time frame: After 24 weeks of treatment Results 1:    Arm/Group Title: Alpelisib + Letrozole   Arm/Group Description: Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.   Overall Number of Participants Analyzed: 60   Measure Type: Number   Unit of Measure: Percentage of Participants  1.7        (0.2 to 6.3) Results 2:    Arm/Group Title: Placebo + Letrozole   Arm/Group Description: Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.   Overall Number of Participants Analyzed: 67   Measure Type: Number   Unit of Measure: Percentage of Participants  3.0        (0.8 to 7.7)