Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Phase II Trial to Assess the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous Recombination Deficiency (HRD Patients With Deleterious BRCA1/2 Tumor or Germline Mutation and/or HRD Score High)
Brief Summary: This is a multicenter, prospective, randomized, open-label phase II study evaluating the efficacy and safety of PO→EC as neoadjuvant treatment of operable and locally advanced breast cancer in patients with HR deficiency. Patients will be randomized to receive

* paclitaxel 80 mg/m² iv weekly in combination with olaparib tablets 100 mg (4X25mg) twice daily for 12 weeks (65 patients) or
* paclitaxel 80 mg/m² iv weekly in combination with carboplatin AUC 2 iv weekly for 12 weeks (37 patients) both followed by 4 cycles of epirubicin 90 mg/m² and cyclophosphamide 600 mg/m² (EC) either every 3 or every 2 weeks followed by surgery.

The control arm was chosen to allow direct comparison with one of the currently considered standard of care regimen.


Options:
A: 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)
B: Arm Label: Paclitaxel with Carboplatin (PwCb); Type: ACTIVE_COMPARATOR; Interventions: Drug: PwCb, Drug: EC, Procedure: Surgery after neoadjuvant Therapy, Other: Stratification | Arm Label: Paclitaxel with Olaparib (PwO); Type: EXPERIMENTAL; Interventions: Drug: PwO, Drug: EC, Procedure: Surgery after neoadjuvant Therapy, Other: Stratification | Intervention Type: DRUG; Name: PwO; Assigned to Arm(s): Paclitaxel with Olaparib (PwO) | Intervention Type: DRUG; Name: PwCb; Assigned to Arm(s): Paclitaxel with Carboplatin (PwCb) | Intervention Type: DRUG; Name: EC; Assigned to Arm(s): Paclitaxel with Carboplatin (PwCb), Paclitaxel with Olaparib (PwO) | Intervention Type: PROCEDURE; Name: Surgery after neoadjuvant Therapy; Assigned to Arm(s): Paclitaxel with Carboplatin (PwCb), Paclitaxel with Olaparib (PwO) | Intervention Type: OTHER; Name: Stratification; Assigned to Arm(s): Paclitaxel with Carboplatin (PwCb), Paclitaxel with Olaparib (PwO)
C: Arm Label: Anthracycline - Taxane; Type: ACTIVE_COMPARATOR; Interventions: Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Docetaxel, Drug: Paclitaxel | Arm Label: Taxane - Anthracycline; Type: EXPERIMENTAL; Interventions: Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Docetaxel, Drug: Paclitaxel | Intervention Type: DRUG; Name: Epirubicin; Assigned to Arm(s): Anthracycline - Taxane, Taxane - Anthracycline | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): Anthracycline - Taxane, Taxane - Anthracycline | Intervention Type: DRUG; Name: Docetaxel; Assigned to Arm(s): Anthracycline - Taxane, Taxane - Anthracycline | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Anthracycline - Taxane, Taxane - Anthracycline
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: B