45 A Phase 3 Randomized Study of Adjuvant Sacituzumab Tirumotecan Plus Pembrolizumab vs Treatment of Physician’s Choice in Patients With Triple-Negative Breast Cancer Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response at Surgery

Publication
Article
Miami Breast Cancer Conference® Abstracts Supplement42nd Annual Miami Breast Cancer Conference® - Abstracts
Volume 39
Issue 4
Pages: 25-26

45 A Phase 3 Randomized Study of Adjuvant Sacituzumab Tirumotecan Plus Pembrolizumab vs Treatment of Physician’s Choice in Patients With Triple-Negative Breast Cancer Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response at Surgery

45 A Phase 3 Randomized Study of Adjuvant Sacituzumab Tirumotecan Plus Pembrolizumab vs Treatment of Physician’s Choice in Patients With Triple-Negative Breast Cancer Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response at Surgery

Background

TROP2 expression is higher in triple-negative breast cancer (TNBC) vs other breast cancer subtypes, and high expression is associated with poor prognosis. Sacituzumab tirumotecan (also known as MK-2870/SKB264) is a novel antibody-drug conjugate composed of anti-TROP2 antibody coupled to a cytotoxic belotecan derivative via a novel linker (average drug/antibody ratio, 7.4). In a prior phase 3 study OptiTROP-Breast01 (NCT05347134), sacituzumab tirumotecan alone improved progression-free survival (HR, 0.31; 95% CI, 0.22-0.45; P <.00001) and overall survival (OS; HR, 0.53; 95% CI, 0.36-0.78; P = .0005) vs chemotherapy in patients with heavily pretreated advanced TNBC. The current standard of care (SOC) for patients with newly diagnosed, high-risk, early-stage TNBC is neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab after surgery. Patients who do not achieve pathological complete response (pCR) with the current SOC have higher rates of recurrence and mortality vs patients who achieve pCR. This study (NCT06393374) evaluates adjuvant sacituzumab tirumotecan plus pembrolizumab vs treatment of physician’s choice (pembrolizumab ± capecitabine) in patients with TNBC who received neoadjuvant therapy and did not achieve pCR at surgery.

Materials and Methods

This phase 3, multicenter, open-label study is enrolling patients 18 years and older with centrally confirmed TNBC per the most recent American Society of Clinical Oncology/College of American Pathologists guidelines. Patients have non-pCR after 5 or more cycles of neoadjuvant pembrolizumab plus chemotherapy, including 1 or more cycles of anthracycline-based neoadjuvant therapy. Patients must provide tissue from the surgical specimen for central TROP2 assessment and be able to continue on adjuvant pembrolizumab. Randomization must be conducted 12 weeks or less from surgical resection (window may be extended in consult with the sponsor). Patients are randomized 1:1 to pembrolizumab 400 mg every 6 weeks for 5 doses plus sacituzumab tirumotecan 4 mg/kg every 2 weeks for 12 doses or physician’s choice chemotherapy with pembrolizumab at 400 mg every 6 weeks for 5 doses with or without capecitabine at 1000 to 1250 mg/m2 twice daily on days 1 to 14 and days 22 to 35 every 42 days for 4 cycles until completion of therapy or disease recurrence, unacceptable toxicity, or withdrawal. Randomization is stratified by residual tumor and lymph node status, TROP2 expression, and intention to use capecitabine. Primary end point is invasive disease-free survival. Secondary end points are OS, distant recurrence-free survival, patient-reported outcomes, and safety.

Status

Enrollment began in Q2 2024.

Articles in this issue

10 AI as a Bridge: Can ChatGPT Help Patients Understand Their Breast Radiology Reports?
10 AI as a Bridge: Can ChatGPT Help Patients Understand Their Breast Radiology Reports?
12 Gut Microbiome Composition and Pathological Complete Response After Chemotherapy in Breast Cancer: Insights From a Pilot Study
12 Gut Microbiome Composition and Pathological Complete Response After Chemotherapy in Breast Cancer: Insights From a Pilot Study
13 Preliminary Analysis of Change During Treatment of Financial Toxicity and Quality of Life in Breast Cancer Patients
13 Preliminary Analysis of Change During Treatment of Financial Toxicity and Quality of Life in Breast Cancer Patients
15 Utilizing Circulating Tumor Cells to Guide HER2-Directed Therapy in IHC/FISH-Negative HER2+ Metastatic Breast Cancer
15 Utilizing Circulating Tumor Cells to Guide HER2-Directed Therapy in IHC/FISH-Negative HER2+ Metastatic Breast Cancer
16 A Miami Hospital’s Infrastructure to Help Decrease Late-Stage Breast Cancer Diagnosis and Improve Health Equity
16 A Miami Hospital’s Infrastructure to Help Decrease Late-Stage Breast Cancer Diagnosis and Improve Health Equity
17 Salmonella and the Breast: A Literature Review of Salmonella-Induced Breast Abscesses
17 Salmonella and the Breast: A Literature Review of Salmonella-Induced Breast Abscesses
18 Tolerability of First-Line Treatment With Ribociclib for Metastatic Breast Cancer Using 2 Large US Data Sources
18 Tolerability of First-Line Treatment With Ribociclib for Metastatic Breast Cancer Using 2 Large US Data Sources
20 Impact of Ribociclib Dose Reduction on Efficacy in Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast
20 Impact of Ribociclib Dose Reduction on Efficacy in Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast
21 Distant Disease-Free Survival Across Key Subgroups From the Phase 3 NATALEE Trial of Ribociclib Plus a Nonsteroidal Aromatase Inhibitor in Patients With HR+/HER2− Early Breast Cancer
21 Distant Disease-Free Survival Across Key Subgroups From the Phase 3 NATALEE Trial of Ribociclib Plus a Nonsteroidal Aromatase Inhibitor in Patients With HR+/HER2− Early Breast Cancer
22 Efficacy and Safety of Ribociclib + Nonsteroidal Aromatase Inhibitor in Younger Patients With HR+/HER2− Early Breast Cancer in NATALEE
22 Efficacy and Safety of Ribociclib + Nonsteroidal Aromatase Inhibitor in Younger Patients With HR+/HER2− Early Breast Cancer in NATALEE
23 Clinical Outcomes in Patients With HR+/HER2− Early Breast Cancer By Prior Systemic Treatment: A Subgroup Analysis of the NATALEE Trial
23 Clinical Outcomes in Patients With HR+/HER2− Early Breast Cancer By Prior Systemic Treatment: A Subgroup Analysis of the NATALEE Trial
TPS 24 Phase Ib Dose-Finding Study of [177Lu]Lu-NeoB + Ribociclib + Fulvestrant in Patients With ER+/HER2− Advanced Breast Cancer With GRPR Expression With Early Relapse FromAdjuvant Endocrine Therapy or Progression on ET + CDK4/6i for ABC
TPS 24 Phase Ib Dose-Finding Study of [177Lu]Lu-NeoB + Ribociclib + Fulvestrant in Patients With ER+/HER2− Advanced Breast Cancer With GRPR Expression With Early Relapse FromAdjuvant Endocrine Therapy or Progression on ET + CDK4/6i for ABC
TPS 25 Phase 1/2 Study of the Novel Radioligand Therapy [177Lu]Lu-NeoB Plus Capecitabine in Patients With ER+/HER2− Advanced Breast Cancer (ABC) With GRPR Expression After Progression on Prior Endocrine Therapy Plus a CDK4/6 Inhibitor for ABC
TPS 25 Phase 1/2 Study of the Novel Radioligand Therapy [177Lu]Lu-NeoB Plus Capecitabine in Patients With ER+/HER2− Advanced Breast Cancer (ABC) With GRPR Expression After Progression on Prior Endocrine Therapy Plus a CDK4/6 Inhibitor for ABC
26 Risk of Recurrence in Real-World NATALEE- and monarchE-Eligible Populations of Patients With HR+/HER2− Early Breast Cancer in an Electronic Health Record-Derived Database
26 Risk of Recurrence in Real-World NATALEE- and monarchE-Eligible Populations of Patients With HR+/HER2− Early Breast Cancer in an Electronic Health Record-Derived Database
27 Elacestrant vs Standard of Care in ER+, HER2- Advanced or Metastatic Breast Cancer With ESR1-Mutated Tumors: ESR1 Allelic Frequencies and Clinical Activity From the Phase 3 EMERALD Trial
27 Elacestrant vs Standard of Care in ER+, HER2- Advanced or Metastatic Breast Cancer With ESR1-Mutated Tumors: ESR1 Allelic Frequencies and Clinical Activity From the Phase 3 EMERALD Trial
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