Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC).

After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence.

The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.


Options:
A: Arm Label: Pembrolizumab + Chemotherapy; Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab, Drug: Carboplatin, Drug: Paclitaxel, Drug: Doxorubicin, Drug: Epirubicin, Drug: Cyclophosphamide, Biological: Granulocyte colony stimulating factor: Filgrastim or Pegfilgastrim | Arm Label: Placebo + Chemotherapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Carboplatin, Drug: Paclitaxel, Drug: Doxorubicin, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Placebo, Biological: Granulocyte colony stimulating factor: Filgrastim or Pegfilgastrim | Intervention Type: BIOLOGICAL; Name: Pembrolizumab; Assigned to Arm(s): Pembrolizumab + Chemotherapy | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): Pembrolizumab + Chemotherapy, Placebo + Chemotherapy | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Pembrolizumab + Chemotherapy, Placebo + Chemotherapy | Intervention Type: DRUG; Name: Doxorubicin; Assigned to Arm(s): Pembrolizumab + Chemotherapy, Placebo + Chemotherapy | Intervention Type: DRUG; Name: Epirubicin; Assigned to Arm(s): Pembrolizumab + Chemotherapy, Placebo + Chemotherapy | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): Pembrolizumab + Chemotherapy, Placebo + Chemotherapy | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo + Chemotherapy | Intervention Type: BIOLOGICAL; Name: Granulocyte colony stimulating factor: Filgrastim or Pegfilgastrim; Assigned to Arm(s): Pembrolizumab + Chemotherapy, Placebo + Chemotherapy
B: Arm Label: Arm I (paclitaxel, doxorubicin, cyclophosphamide); Type: ACTIVE_COMPARATOR; Interventions: Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel | Arm Label: Arm II (paclitaxel, ddAC, bevacizumab); Type: EXPERIMENTAL; Interventions: Biological: Bevacizumab, Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel | Arm Label: Arm III (paclitaxel, ddAC, carboplatin); Type: EXPERIMENTAL; Interventions: Drug: Carboplatin, Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel | Arm Label: Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin); Type: EXPERIMENTAL; Interventions: Biological: Bevacizumab, Drug: Carboplatin, Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel | Intervention Type: BIOLOGICAL; Name: Bevacizumab; Assigned to Arm(s): Arm II (paclitaxel, ddAC, bevacizumab), Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin) | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): Arm III (paclitaxel, ddAC, carboplatin), Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin) | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): Arm I (paclitaxel, doxorubicin, cyclophosphamide), Arm II (paclitaxel, ddAC, bevacizumab), Arm III (paclitaxel, ddAC, carboplatin), Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin) | Intervention Type: DRUG; Name: Doxorubicin Hydrochloride; Assigned to Arm(s): Arm I (paclitaxel, doxorubicin, cyclophosphamide), Arm II (paclitaxel, ddAC, bevacizumab), Arm III (paclitaxel, ddAC, carboplatin), Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm I (paclitaxel, doxorubicin, cyclophosphamide), Arm II (paclitaxel, ddAC, bevacizumab), Arm III (paclitaxel, ddAC, carboplatin), Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin) | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Arm I (paclitaxel, doxorubicin, cyclophosphamide), Arm II (paclitaxel, ddAC, bevacizumab), Arm III (paclitaxel, ddAC, carboplatin), Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin)
C: Arm Label: PM(Cb); Type: EXPERIMENTAL; Interventions: Drug: non-pegylated liposomal doxorubicin, Drug: Carboplatin, Drug: Paclitaxel, Drug: Pertuzumab, Drug: Trastuzumab, Drug: Ferric carboxymaltose | Arm Label: ETC; Type: ACTIVE_COMPARATOR; Interventions: Drug: Paclitaxel, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Pertuzumab, Drug: Trastuzumab, Drug: Ferric carboxymaltose | Intervention Type: DRUG; Name: non-pegylated liposomal doxorubicin; Assigned to Arm(s): PM(Cb) | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): PM(Cb) | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): ETC, PM(Cb) | Intervention Type: DRUG; Name: Epirubicin; Assigned to Arm(s): ETC | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): ETC | Intervention Type: DRUG; Name: Pertuzumab; Assigned to Arm(s): ETC, PM(Cb) | Intervention Type: DRUG; Name: Trastuzumab; Assigned to Arm(s): ETC, PM(Cb) | Intervention Type: DRUG; Name: Ferric carboxymaltose; Assigned to Arm(s): ETC, PM(Cb)
D: Arm Label: Standard Therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard Therapy | Arm Label: AMG 386 with or without Trastuzumab; Type: EXPERIMENTAL; Interventions: Drug: AMG 386 with or without Trastuzumab, Drug: AMG 386 and Trastuzumab | Arm Label: AMG 479 plus Metformin; Type: OTHER; Interventions: Drug: AMG 479 (Ganitumab) plus Metformin | Arm Label: MK-2206 with or without Trastuzumab; Type: EXPERIMENTAL; Interventions: Drug: MK-2206 with or without Trastuzumab | Arm Label: T-DM1 and Pertuzumab; Type: EXPERIMENTAL; Interventions: Drug: T-DM1 and Pertuzumab | Arm Label: Pertuzumab and Trastuzumab; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pertuzumab and Trastuzumab | Arm Label: Ganetespib; Type: EXPERIMENTAL; Interventions: Drug: Ganetespib | Arm Label: ABT-888; Type: OTHER; Interventions: Drug: ABT-888 | Arm Label: Neratinib; Type: OTHER; Interventions: Drug: Neratinib | Arm Label: PLX3397; Type: EXPERIMENTAL; Interventions: Drug: PLX3397 | Arm Label: Pembrolizumab 4 cycle; Type: EXPERIMENTAL; Interventions: Drug: Pembrolizumab - 4 cycle | Arm Label: Talazoparib plus Irinotecan; Type: EXPERIMENTAL; Interventions: Drug: Talazoparib plus Irinotecan | Arm Label: Patritumab with or without Trastuzumab; Type: EXPERIMENTAL; Interventions: Drug: Patritumab and Trastuzumab | Arm Label: Pembrolizumab 8 cycle; Type: EXPERIMENTAL; Interventions: Drug: Pembrolizumab - 8 cycle | Arm Label: SGN-LIV1A; Type: EXPERIMENTAL; Interventions: Drug: SGN-LIV1A | Arm Label: Durvalumab plus Olaparib; Type: EXPERIMENTAL; Interventions: Drug: Durvalumab plus Olaparib | Arm Label: SD-101 + Pembrolizumab; Type: EXPERIMENTAL; Interventions: Drug: SD-101 + Pembrolizumab | Arm Label: Tucatinib; Type: EXPERIMENTAL; Interventions: Drug: Tucatinib plus trastuzumab and pertuzumab | Arm Label: Cemiplimab; Type: EXPERIMENTAL; Interventions: Drug: Cemiplimab | Arm Label: Cemiplimab plus REGN3767; Type: EXPERIMENTAL; Interventions: Drug: Cemiplimab plus REGN3767 | Arm Label: Trilaciclib with or without trastuzumab + pertuzumab; Type: EXPERIMENTAL; Interventions: Drug: Trilaciclib with or without trastuzumab + pertuzumab | Arm Label: SYD985 ([vic-]trastuzumab duocarmazine); Type: EXPERIMENTAL; Interventions: Drug: SYD985 ([vic-]trastuzumab duocarmazine) | Arm Label: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab; Type: EXPERIMENTAL; Interventions: Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab | Arm Label: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab; Type: EXPERIMENTAL; Interventions: Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab | Arm Label: Endocrine Optimization Pilot: Amcenestrant Monotherapy; Type: EXPERIMENTAL; Interventions: Drug: Amcenestrant | Arm Label: Endocrine Optimization Pilot: Amcenestrant + Abemaciclib; Type: EXPERIMENTAL; Interventions: Drug: Amcenestrant + Abemaciclib | Arm Label: Endocrine Optimization Pilot: Amcenestrant + Letrozole; Type: EXPERIMENTAL; Interventions: Drug: Amcenestrant + Letrozole | Arm Label: ARX788 in Block A and followed by SOC in Block B; Type: EXPERIMENTAL; Interventions: Drug: ARX788 | Arm Label: ARX788 + Cemiplimab in Block A and followed by SOC in Block B; Type: EXPERIMENTAL; Interventions: Drug: ARX788 + Cemiplimab | Arm Label: VSV-IFNβ-NIS (VOYAGER V1™; VV1) + Cemiplimab in Block A and followed by SOC in block B; Type: EXPERIMENTAL; Interventions: Drug: VV1 + Cemiplimab | Arm Label: Datopotamab Deruxtecan in Block A and followed by SOC in block B; Type: EXPERIMENTAL; Interventions: Drug: Datopotamab deruxtecan | Arm Label: Datopotamab Deruxtecan + Durvalumab in Block A and followed by SOC in block B; Type: EXPERIMENTAL; Interventions: Drug: Datopotamab deruxtecan + Durvalumab | Arm Label: Zanidatamab in Block A and followed by SOC in block B; Type: EXPERIMENTAL; Interventions: Drug: Zanidatamab | Arm Label: Endocrine Optimization Pilot: Lasofoxifene; Type: EXPERIMENTAL; Interventions: Drug: Lasofoxifene | Arm Label: Endocrine Optimization Pilot: (Z)-Endoxifen; Type: EXPERIMENTAL; Interventions: Drug: Z-endoxifen | Arm Label: Endocrine Optimization Pilot: ARV-471; Type: EXPERIMENTAL; Interventions: Drug: ARV-471 | Arm Label: Endocrine Optimization Pilot: ARV-471 + Letrozole; Type: EXPERIMENTAL; Interventions: Drug: ARV-471 + Letrozole | Arm Label: Endocrine Optimization Pilot: ARV-471 + Abemaciclib; Type: EXPERIMENTAL; Interventions: Drug: ARV-471 + Abemaciclib | Arm Label: Endocrine Optimization Pilot: (Z)-Endoxifen + Abemaciclib; Type: EXPERIMENTAL; Interventions: Drug: Endoxifen + Abemaciclib | Arm Label: Rilvegostomig + TDXd in Block A and followed by SOC in Block B; Type: EXPERIMENTAL; Interventions: Drug: Rilvegostomig + TDXd | Arm Label: DAN222 + Niraparib in Block A and followed by SOC in Block B; Type: EXPERIMENTAL; Interventions: Drug: Dan222 + Niraparib | Arm Label: Sarilumab + Cemiplimab + Paclitaxel in Block B followed by SOC Block C; Type: EXPERIMENTAL; Interventions: Drug: Sarilumab + Cemiplimab + Paclitaxel | Intervention Type: DRUG; Name: Standard Therapy; Assigned to Arm(s): Standard Therapy | Intervention Type: DRUG; Name: AMG 386 with or without Trastuzumab; Assigned to Arm(s): AMG 386 with or without Trastuzumab | Intervention Type: DRUG; Name: AMG 479 (Ganitumab) plus Metformin; Assigned to Arm(s): AMG 479 plus Metformin | Intervention Type: DRUG; Name: MK-2206 with or without Trastuzumab; Assigned to Arm(s): MK-2206 with or without Trastuzumab | Intervention Type: DRUG; Name: AMG 386 and Trastuzumab; Assigned to Arm(s): AMG 386 with or without Trastuzumab | Intervention Type: DRUG; Name: T-DM1 and Pertuzumab; Assigned to Arm(s): T-DM1 and Pertuzumab | Intervention Type: DRUG; Name: Pertuzumab and Trastuzumab; Assigned to Arm(s): Pertuzumab and Trastuzumab | Intervention Type: DRUG; Name: Ganetespib; Assigned to Arm(s): Ganetespib | Intervention Type: DRUG; Name: ABT-888; Assigned to Arm(s): ABT-888 | Intervention Type: DRUG; Name: Neratinib; Assigned to Arm(s): Neratinib | Intervention Type: DRUG; Name: PLX3397; Assigned to Arm(s): PLX3397 | Intervention Type: DRUG; Name: Pembrolizumab - 4 cycle; Assigned to Arm(s): Pembrolizumab 4 cycle | Intervention Type: DRUG; Name: Talazoparib plus Irinotecan; Assigned to Arm(s): Talazoparib plus Irinotecan | Intervention Type: DRUG; Name: Patritumab and Trastuzumab; Assigned to Arm(s): Patritumab with or without Trastuzumab | Intervention Type: DRUG; Name: Pembrolizumab - 8 cycle; Assigned to Arm(s): Pembrolizumab 8 cycle | Intervention Type: DRUG; Name: SGN-LIV1A; Assigned to Arm(s): SGN-LIV1A | Intervention Type: DRUG; Name: Durvalumab plus Olaparib; Assigned to Arm(s): Durvalumab plus Olaparib | Intervention Type: DRUG; Name: SD-101 + Pembrolizumab; Assigned to Arm(s): SD-101 + Pembrolizumab | Intervention Type: DRUG; Name: Tucatinib plus trastuzumab and pertuzumab; Assigned to Arm(s): Tucatinib | Intervention Type: DRUG; Name: Cemiplimab; Assigned to Arm(s): Cemiplimab | Intervention Type: DRUG; Name: Cemiplimab plus REGN3767; Assigned to Arm(s): Cemiplimab plus REGN3767 | Intervention Type: DRUG; Name: Trilaciclib with or without trastuzumab + pertuzumab; Assigned to Arm(s): Trilaciclib with or without trastuzumab + pertuzumab | Intervention Type: DRUG; Name: SYD985 ([vic-]trastuzumab duocarmazine); Assigned to Arm(s): SYD985 ([vic-]trastuzumab duocarmazine) | Intervention Type: DRUG; Name: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab; Assigned to Arm(s): Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab | Intervention Type: DRUG; Name: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab; Assigned to Arm(s): Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab | Intervention Type: DRUG; Name: Amcenestrant; Assigned to Arm(s): Endocrine Optimization Pilot: Amcenestrant Monotherapy | Intervention Type: DRUG; Name: Amcenestrant + Abemaciclib; Assigned to Arm(s): Endocrine Optimization Pilot: Amcenestrant + Abemaciclib | Intervention Type: DRUG; Name: Amcenestrant + Letrozole; Assigned to Arm(s): Endocrine Optimization Pilot: Amcenestrant + Letrozole | Intervention Type: DRUG; Name: ARX788; Assigned to Arm(s): ARX788 in Block A and followed by SOC in Block B | Intervention Type: DRUG; Name: ARX788 + Cemiplimab; Assigned to Arm(s): ARX788 + Cemiplimab in Block A and followed by SOC in Block B | Intervention Type: DRUG; Name: VV1 + Cemiplimab; Assigned to Arm(s): VSV-IFNβ-NIS (VOYAGER V1™; VV1) + Cemiplimab in Block A and followed by SOC in block B | Intervention Type: DRUG; Name: Datopotamab deruxtecan; Assigned to Arm(s): Datopotamab Deruxtecan in Block A and followed by SOC in block B | Intervention Type: DRUG; Name: Datopotamab deruxtecan + Durvalumab; Assigned to Arm(s): Datopotamab Deruxtecan + Durvalumab in Block A and followed by SOC in block B | Intervention Type: DRUG; Name: Zanidatamab; Assigned to Arm(s): Zanidatamab in Block A and followed by SOC in block B | Intervention Type: DRUG; Name: Lasofoxifene; Assigned to Arm(s): Endocrine Optimization Pilot: Lasofoxifene | Intervention Type: DRUG; Name: Z-endoxifen; Assigned to Arm(s): Endocrine Optimization Pilot: (Z)-Endoxifen | Intervention Type: DRUG; Name: ARV-471; Assigned to Arm(s): Endocrine Optimization Pilot: ARV-471 | Intervention Type: DRUG; Name: ARV-471 + Letrozole; Assigned to Arm(s): Endocrine Optimization Pilot: ARV-471 + Letrozole | Intervention Type: DRUG; Name: ARV-471 + Abemaciclib; Assigned to Arm(s): Endocrine Optimization Pilot: ARV-471 + Abemaciclib | Intervention Type: DRUG; Name: Endoxifen + Abemaciclib; Assigned to Arm(s): Endocrine Optimization Pilot: (Z)-Endoxifen + Abemaciclib | Intervention Type: DRUG; Name: Rilvegostomig + TDXd; Assigned to Arm(s): Rilvegostomig + TDXd in Block A and followed by SOC in Block B | Intervention Type: DRUG; Name: Dan222 + Niraparib; Assigned to Arm(s): DAN222 + Niraparib in Block A and followed by SOC in Block B | Intervention Type: DRUG; Name: Sarilumab + Cemiplimab + Paclitaxel; Assigned to Arm(s): Sarilumab + Cemiplimab + Paclitaxel in Block B followed by SOC Block C

Answer: A