Statement: 16 participants of the primary trial are considered to be censored. the secondary trial used the same outcome measurement, but had no censored patients.
Primary_evidence: Outcome Measurement:    Number of Participants With Progression Free Survival (PFS)   Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have exhibited a reduction in short axis to < 10 mm. Partial Response (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): at least 20% increase in sum of diameters of target lesions taking as reference the smallest sum on study accompanied by an absolute increase of at least 5 mm or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PFS is time from enrollment to date of first documented disease progression or death due to any cause. A participant is considered to be censored when data on time to event is missing due to a subject being lost to follow-up or non-occurrence of the outcome event before the completion of the trial.   Time frame: up to 18 months Results 1:    Arm/Group Title: Patients Without Bone Metastases   Arm/Group Description: Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.   Overall Number of Participants Analyzed: 15   Measure Type: Number   Unit of Measure: Participants  Event: 9 Censor: 6 Results 2:    Arm/Group Title: Patients With Bone Metastases   Arm/Group Description: Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)   Overall Number of Participants Analyzed: 29   Measure Type: Number   Unit of Measure: Participants  Event: 19 Censor: 10
Secondary_evidence: Outcome Measurement:    Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment   IRF assessed PFS was defined as time (in months) from randomization until the date of first documented radiologic progressive disease per response evaluation criteria in solid tumors (RECIST) version 1.1 or death from any cause, whichever occurs first. As per RECIST v1.1, progression defined as 1) for target lesions: at least a 20% increase in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), the absolute increase in the sum has to be at least 5 millimeter (mm); 2) for non-target lesions: unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions; 3) and/or appearance of one or more new lesions. The analysis was performed by Kaplan-Meier method.   Time frame: Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 months) Results 1:    Arm/Group Title: Talazoparib   Arm/Group Description: Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.   Overall Number of Participants Analyzed: 287   Median (95% Confidence Interval)   Unit of Measure: months  8.6        (7.2 to 9.3) Results 2:    Arm/Group Title: Physician's Choice Treatment   Arm/Group Description: Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.   Overall Number of Participants Analyzed: 144   Median (95% Confidence Interval)   Unit of Measure: months  5.6        (4.2 to 6.7)