Estela Vega

Talimogene laherparepvec and atezolizumab in HER2-negative breast cancer following neoadjuvant chemotherapy: a window-of-opportunity phase II trial (SOLTI-1503 PROMETEO)

Tomás Pascual, Maria Vidal, Juan Miguel Cejalvo, Estela Vega et autres

PFU/mL) plus atezolizumab (840 mg, intravenously). Among the 28 patients enrolled, 20 patients (71.4%) had HR+/HER2-negative and 8 patients (28.6%) had TNBC. At surgery, 7 patients (26.9%) achieved Residual Cancer Burden (RCB)-0/I (primary endpoint), 12 (46.2%) RCB-II and 7 (26.9%) RCB-III. Safety …

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Supplementary Figure S2 from Addition of Ipatasertib to Dual Anti-HER2 Maintenance Therapy in HER2-Positive Metastatic Breast Tumors with PIK3CA Mutations: The Phase Ib SOLTI-1507 IPATHER Trial

Mafalda Oliveira, Eva Ciruelos, Guillermo Javierre Villacampa, Serafín Morales et autres

Supplementary Figure S2 | Dose de-escalation design and criteria to dose expansion. aIf ≥2 DLT occur in the first six patients, a decision had to be made on whether to expand DL1 to 10 additional patients or to de-escalate ipatasertib dose to …

Supplementary Data S2 from Addition of Ipatasertib to Dual Anti-HER2 Maintenance Therapy in HER2-Positive Metastatic Breast Tumors with PIK3CA Mutations: The Phase Ib SOLTI-1507 IPATHER Trial

Mafalda Oliveira, Eva Ciruelos, Guillermo Javierre Villacampa, Serafín Morales et autres

Supplementary Data S2. Study Protocol

Supplementary Figure S4 from Addition of Ipatasertib to Dual Anti-HER2 Maintenance Therapy in HER2-Positive Metastatic Breast Tumors with PIK3CA Mutations: The Phase Ib SOLTI-1507 IPATHER Trial

Mafalda Oliveira, Eva Ciruelos, Guillermo Javierre Villacampa, Serafín Morales et autres

Supplementary Figure S4 | Progression-free survival in the efficacy cohort since the initiation of first-line treatment for advanced disease (N = 16). Kaplan-Meier curve from the first-line treatment for metastatic breast cancer with trastuzumab plus pertuzumab plus chemotherapy. CI, confidence interval; NR; …

Supplementary Table S2 from Addition of Ipatasertib to Dual Anti-HER2 Maintenance Therapy in HER2-Positive Metastatic Breast Tumors with PIK3CA Mutations: The Phase Ib SOLTI-1507 IPATHER Trial

Mafalda Oliveira, Eva Ciruelos, Guillermo Javierre Villacampa, Serafín Morales et autres

Supplementary Table S2 | Criteria for defining DLT. AE, adverse events; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CTCAE, Common Terminology Criteria for Adverse Events; DLT, dose-limiting toxicities; GI, gastrointestinal; LLN, lower limit of normal; SOC, standard of care; ULN, upper limit of …

Supplementary Data S3 from Addition of Ipatasertib to Dual Anti-HER2 Maintenance Therapy in HER2-Positive Metastatic Breast Tumors with PIK3CA Mutations: The Phase Ib SOLTI-1507 IPATHER Trial

Mafalda Oliveira, Eva Ciruelos, Guillermo Javierre Villacampa, Serafín Morales et autres

Supplementary data S3. Analysis outputs

Supplementary Table S4 from Addition of Ipatasertib to Dual Anti-HER2 Maintenance Therapy in HER2-Positive Metastatic Breast Tumors with PIK3CA Mutations: The Phase Ib SOLTI-1507 IPATHER Trial

Mafalda Oliveira, Eva Ciruelos, Guillermo Javierre Villacampa, Serafín Morales et autres

Supplementary Table S4 | Drug-related dose interruptions, dose reductions, and treatment discontinuations (N = 17)

Supplementary Figure S3 from Addition of Ipatasertib to Dual Anti-HER2 Maintenance Therapy in HER2-Positive Metastatic Breast Tumors with PIK3CA Mutations: The Phase Ib SOLTI-1507 IPATHER Trial

Mafalda Oliveira, Eva Ciruelos, Guillermo Javierre Villacampa, Serafín Morales et autres

Supplementary Figure S3 | Translational genomic analysis of screened patients (N = 116). Oncoplot depicting the genomic landscape of all screened patients. ER, estrogen receptor; IHC, immunohistochemistry; ISH, in situ hybridization; NA, not available; PR, progesterone receptor.

Supplementary Table S1 from Addition of Ipatasertib to Dual Anti-HER2 Maintenance Therapy in HER2-Positive Metastatic Breast Tumors with PIK3CA Mutations: The Phase Ib SOLTI-1507 IPATHER Trial

Mafalda Oliveira, Eva Ciruelos, Guillermo Javierre Villacampa, Serafín Morales et autres

Supplementary Table S1 | Representativeness of Study Participants

Supplementary Table S3 from Addition of Ipatasertib to Dual Anti-HER2 Maintenance Therapy in HER2-Positive Metastatic Breast Tumors with PIK3CA Mutations: The Phase Ib SOLTI-1507 IPATHER Trial

Mafalda Oliveira, Eva Ciruelos, Guillermo Javierre Villacampa, Serafín Morales et autres

Supplementary Table S3 | Treatment-Emergent Adverse Events (TEAE) and serious TEAE in the study safety population (N = 17)

Data from Addition of Ipatasertib to Dual Anti-HER2 Maintenance Therapy in HER2-Positive Metastatic Breast Tumors with PIK3CA Mutations: The Phase Ib SOLTI-1507 IPATHER Trial

Mafalda Oliveira, Eva Ciruelos, Guillermo Javierre Villacampa, Serafín Morales et autres

AbstractPurpose: The aim of this study was to evaluate the safety and feasibility of ipatasertib combined with trastuzumab and pertuzumab (HP) as maintenance therapy after first-line treatment in patients with HER2-positive metastatic breast cancer harboring PIK3CA mutations (PIK3CAmut). Patients and Methods: This …

Supplementary Figure S1 from Addition of Ipatasertib to Dual Anti-HER2 Maintenance Therapy in HER2-Positive Metastatic Breast Tumors with PIK3CA Mutations: The Phase Ib SOLTI-1507 IPATHER Trial

Mafalda Oliveira, Eva Ciruelos, Guillermo Javierre Villacampa, Serafín Morales et autres

Supplementary Figure S1 | IPATHER trial design. aPatients could be pre-screened before or during induction treatment with chemotherapy and dual anti-HER2 blockade regimen. Patients who were HER2-positive and harbored a PIK3CA mutation, identified in archival or fresh tumor tissue samples (from primary …