Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Multi-Center, Open-Label, Randomized Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer
Brief Summary: The goal of this study was to determine the effect on overall survival and progression free survival by adding iniparib (BSI-201/SAR240550) to the combination of gemcitabine/carboplatin in adult patients with triple negative breast cancer (estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2)-negative).

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the poly (ADP-ribose) polymerase (PARP) inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.


Options:
A: Arm Label: Atezolizumab Plus Nab-Paclitaxel; Type: EXPERIMENTAL; Interventions: Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Drug: Nab-Paclitaxel | Arm Label: Placebo Plus Nab-Paclitaxel; Type: PLACEBO_COMPARATOR; Interventions: Drug: Nab-Paclitaxel, Drug: Placebo | Intervention Type: DRUG; Name: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody; Assigned to Arm(s): Atezolizumab Plus Nab-Paclitaxel | Intervention Type: DRUG; Name: Nab-Paclitaxel; Assigned to Arm(s): Atezolizumab Plus Nab-Paclitaxel, Placebo Plus Nab-Paclitaxel | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo Plus Nab-Paclitaxel
B: Arm Label: Veliparib with Temozolomide; Type: EXPERIMENTAL; Interventions: Drug: Veliparib, Drug: Temozolomide | Arm Label: Placebo with Carboplatin and Paclitaxel; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Carboplatin, Drug: Paclitaxel | Arm Label: Veliparib with Carboplatin and Paclitaxel; Type: EXPERIMENTAL; Interventions: Drug: Veliparib, Drug: Carboplatin, Drug: Paclitaxel | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo with Carboplatin and Paclitaxel | Intervention Type: DRUG; Name: Veliparib; Assigned to Arm(s): Veliparib with Carboplatin and Paclitaxel, Veliparib with Temozolomide | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): Placebo with Carboplatin and Paclitaxel, Veliparib with Carboplatin and Paclitaxel | Intervention Type: DRUG; Name: Temozolomide; Assigned to Arm(s): Veliparib with Temozolomide | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Placebo with Carboplatin and Paclitaxel, Veliparib with Carboplatin and Paclitaxel
C: Arm Label: Arm G/C; Type: ACTIVE_COMPARATOR; Interventions: Drug: gemcitabine/carboplatin | Arm Label: Arm G/C/I; Type: EXPERIMENTAL; Interventions: Drug: gemcitabine/carboplatin, Drug: Iniparib | Intervention Type: DRUG; Name: gemcitabine/carboplatin; Assigned to Arm(s): Arm G/C, Arm G/C/I | Intervention Type: DRUG; Name: Iniparib; Assigned to Arm(s): Arm G/C/I
D: Arm Label: talazoparib; Type: EXPERIMENTAL; Interventions: Drug: talazoparib | Intervention Type: DRUG; Name: talazoparib; Assigned to Arm(s): talazoparib

Answer: C