Statement: the primary trial and the secondary trial use identical outcome measurements. secondary osteosarcoma is an osteosarcoma arising from a pre-existing lesion of the bone, usually paget disease, or due to radiation therapy.
Primary_evidence: Outcome Measurement:    Overall Response (Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) of Participants   Number of participants experiencing CR, PR or SD as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Response is anyone who experiences SD, CR or PR in first 6 months. CR: Disappearance clinical evidence active tumor by evaluation, mammogram & ultrasound. No symptoms or evidence of residual invasive tumor, including no residual tumor in axillary lymph nodes. PR: 50%/> decrease for minimum 4 weeks in measurable lesion determined by product of perpendicular diameters of lesion. Every lesion should not regress to qualify as PR; however, if lesion progresses or if new lesions appear, response cannot be classified as PR. Minor Response [MR]: Decreases in tumor masses insufficient to qualify as partial remission, i.e. <50%. SD: Between MR & PD. PD: Increase 25% measured lesion from baseline. New lesions constitutes increasing disease. Mixed responses consid   Time frame: 6 months Results 1:    Arm/Group Title: Dovitinib   Arm/Group Description: Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.   Overall Number of Participants Analyzed: 19   Measure Type: Number   Unit of Measure: participants  Complete Response (CR): 0   Partial Response (PR): 0   Stable Disease (SD): 1
Secondary_evidence: Outcome Measurement:    Percentage of Participants With Pathological Complete Response (pCR) in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in All Participants)   pCR was defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer (AJCC) Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes.   Time frame: Surgery visit (at approximately Weeks 14 to 19) Results 1:    Arm/Group Title: Ipatasertib + Paclitaxel   Arm/Group Description: Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).   Overall Number of Participants Analyzed: 76   Measure Type: Number   Unit of Measure: percentage of participants  17.1        (9.82 to 27.25) Results 2:    Arm/Group Title: Placebo + Paclitaxel   Arm/Group Description: Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).   Overall Number of Participants Analyzed: 75   Measure Type: Number   Unit of Measure: percentage of participants  13.3        (6.58 to 22.86)