Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
Brief Summary: This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Participants could have received one prior hormonal treatment for MBC. Participants may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the participant had experienced a disease-free interval (DFI) of greater than or equal to (≥)12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Participants may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment.

Participants were randomized in 1:1 ratio to receive either pertuzumab or placebo, along with trastuzumab and docetaxel once every 3 weeks (q3w), during the treatment phase of the study until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Participants in the Placebo arm were not allowed to receive open-label pertuzumab after discontinuation from study treatment. However, if any analysis of overall survival had met the predefined criteria for statistical significance, participants in the Placebo arm still on treatment were offered the option to receive open-label pertuzumab in addition to other study medications.


Options:
A: Arm Label: Pertuzumab + Trastuzumab + Docetaxel; Type: EXPERIMENTAL; Interventions: Drug: Pertuzumab, Drug: Trastuzumab, Drug: Docetaxel | Arm Label: Placebo + Trastuzumab + Docetaxel; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Trastuzumab, Drug: Docetaxel | Intervention Type: DRUG; Name: Pertuzumab; Assigned to Arm(s): Pertuzumab + Trastuzumab + Docetaxel | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo + Trastuzumab + Docetaxel | Intervention Type: DRUG; Name: Trastuzumab; Assigned to Arm(s): Pertuzumab + Trastuzumab + Docetaxel, Placebo + Trastuzumab + Docetaxel | Intervention Type: DRUG; Name: Docetaxel; Assigned to Arm(s): Pertuzumab + Trastuzumab + Docetaxel, Placebo + Trastuzumab + Docetaxel
B: Arm Label: Upfront surgery; Type: EXPERIMENTAL; Interventions: Procedure: upfront breast surgery | Arm Label: Systemic therapy; Type: OTHER; Interventions: Other: systemic therapy | Intervention Type: PROCEDURE; Name: upfront breast surgery; Assigned to Arm(s): Upfront surgery | Intervention Type: OTHER; Name: systemic therapy; Assigned to Arm(s): Systemic therapy
C: Arm Label: Loco Regional Treatment Arm (LRT); Type: EXPERIMENTAL; Interventions: Procedure: Surgery for breast cancer | Arm Label: No Loco-regional Treatment Arm; Type: ACTIVE_COMPARATOR; Interventions: Other: No Loco-regional treatment | Intervention Type: PROCEDURE; Name: Surgery for breast cancer; Assigned to Arm(s): Loco Regional Treatment Arm (LRT) | Intervention Type: OTHER; Name: No Loco-regional treatment; Assigned to Arm(s): No Loco-regional Treatment Arm
D: Arm Label: A; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: B; Type: OTHER; Interventions: Procedure: Primary surgery | Intervention Type: PROCEDURE; Name: Primary surgery; Assigned to Arm(s): B

Answer: A