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O estudo clínico NCT07407920 para Estágio Anatômico I Câncer de Mama AJCC v8, Estágio Anatômico II Câncer de Mama AJCC v8, Early Stage HER2-Positive Breast Carcinoma, Carcinoma de mama triplo-negativo em estágio inicial está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Centro de Câncer MD AndersonPh2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial Fase II 120 Imunoterapia Terapia alvo
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O estudo clínico NCT07407920 procura avaliar tratamento para Estágio Anatômico I Câncer de Mama AJCC v8, Estágio Anatômico II Câncer de Mama AJCC v8, Early Stage HER2-Positive Breast Carcinoma, Carcinoma de mama triplo-negativo em estágio inicial. Este é um estudo intervencionista de Fase II. Seu status atual é: ativo, não recrutando. O estudo começou em 9 de outubro de 2025 e pretende incluir 120 participantes. Coordenado por o Centro de Câncer MD Anderson e deve ser concluído em 30 de setembro de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 12 de fevereiro de 2026.
Resumo
This phase II trial tests reduced post surgery (adjuvant) therapy for patients with early breast cancer who have confirmed that the disease has responded completely (pathologic complete response) after pre surgical treatment (neoadjuvant) therapy and do not have any tumor genetic material (molecular residual disease) circulating in their blood. Standard of care treatment after surgery consists of 1 year of pembrolizu...Mostrar mais
Descrição detalhada
PRIMARY OBJECTIVES:
I. To determine the 3-year event free survival (EFS) after breast surgery in patients with early triple negative breast cancer (TNBC) that achieve a pathologic complete response (pCR) after neoadjuvant systemic therapy (NST) with a pembrolizumab plus chemotherapy-based regimen and are minimal residual disease (MRD)-negative (negative circulating tumor deoxyribonucleic acid \[ctDNA\] with the NeXT...
Mostrar maisTítulo oficial
Optimization of Adjuvant Systemic Therapy in Patients With Early HER2-Positive (HER2+) Breast Cancer or Triple Negative Breast Cancer (TNBC) That Achieved a Pathological Complete Response (pCR) After Neoadjuvant Systemic Therapy and Do Not Have Molecular Residual Disease (MRD-Negative): A Phase II Clinical Trial (The MolecularPCR Trial)
Condições médicas
Estágio Anatômico I Câncer de Mama AJCC v8Estágio Anatômico II Câncer de Mama AJCC v8Early Stage HER2-Positive Breast CarcinomaCarcinoma de mama triplo-negativo em estágio inicialOutros IDs do estudo
- 2024-1206
- NCI-2025-08252 (Identificador de registro) (CTRP (Clinical Trial Reporting Program))
- 2024-1206 (Outro identificador) (M D Anderson Cancer Center)
- P30CA016672 (Subvenção/Contrato NIH (EUA))
Número NCT
Data de início (real)
2025-10-09
Última atualização postada
2026-02-12
Data de conclusão (estimada)
2027-09-30
Inscrição (estimada)
120
Tipo de estudo
Intervencionista
FASE
Fase II
Status
Ativo, não recrutando
Propósito principal
Tratamento
Alocação do design
Não randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalCohort 1 (Triple negative breast cancer) Patients may receive 1 to 3 cycles of standard of care treatment with pembrolizumab. Patients with a positive ctDNA test 4-6 weeks after surgery continue to receive standard of care treatment per their treating physician in the absence of disease progression or unacceptable toxicity. Patients with a negative ctDNA test will not receive further treatment with pembrolizumab and will undergo monitoring with ctDNA tests ...Mostrar mais | Coleta de biospecimen Undergo blood sample collection Pembrolizumab Given pembrolizumab |
ExperimentalCohort 2 (HER2 positive breast cancer) Patients may receive 1 to 3 cycles of standard of care treatment with trastuzumab with or without pertuzumab. Patients with a positive ctDNA test 4-6 weeks after surgery continue to receive standard of care treatment per their treating physician in the absence of disease progression or unacceptable toxicity. Patients with a negative ctDNA test will not receive further treatment with pembrolizumab and will undergo mon...Mostrar mais | Coleta de biospecimen Undergo blood sample collection Terapia hormonal Given standard of care endocrine therapy Pertuzumab Given pertuzumab Trastuzumab Given trastuzumab |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Event free survival (EFS) | Will be independently estimated for each cohort, along with corresponding 95% confidence intervals using Kaplan-Meier method. | From breast surgery to evidence of clinical locoregional or distant recurrence of breast cancer or death from breast cancer, up to 3 years |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Rate of conversion from negative to positive circulating tumor deoxyribonucleic acid (ctDNA) | 95% confidence interval will be calculated by cohort using the Clopper-Pearson method. | Up to 3 years |
Time to conversion from negative to positive ctDNA | Will be estimated using the Kaplan-Meier method. | Up to 3 years |
Prevalence of patients with pathologic complete response (pCR) rate after receiving neoadjuvant systemic therapy (NST) and have positive ctDNA | The 95% confidence intervals for the prevalence estimates will be calculated using Clopper-Pearson method. | At 4-6 weeks after breast surgery |
EFS in patients that achieve pCR after NST and have a positive ctDNA | EFS at 3 years with their 95% confidence intervals will be estimated using Kaplan-Meier method. Log-rank test will be performed to test the difference in time-to-event distributions between patient groups. | From breast surgery to evidence of clinical locoregional or distant recurrence of breast cancer or death from breast cancer, up to 3 years |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- EARLY HER2 POSITIVE (+) BREAST CANCER COHORT: Female or male with a diagnosis of biopsy proven invasive breast cancer HER2+, hormone (estrogen and progesterone)-receptor positive or negative. The HER2 status (following American Society of Clinical Oncology \[ASCO\]/College of American Pathologists \[CAP\] guidelines) and hormone-receptor status will be determined according to institutional (local) guidelines
- EARLY TNBC COHORT: Female or male with a diagnosis of biopsy proven invasive TNBC (estrogen and progesterone receptor < 10%). The HER2 status (following ASCO/CAP guidelines) and hormone-receptor status will be determined according to institutional (local) guidelines
- FOR BOTH HER2+ AND TNBC COHORTS: Invasive breast cancer of any tumor histologic grade and/or nuclear grade, and any tumor histological subtype including but not limited to infiltrating ductal carcinoma, infiltrating lobular carcinoma, mucinous carcinoma, papillary carcinoma, tubular carcinoma, metaplastic carcinoma, and mixed histology
- FOR BOTH HER2+ AND TNBC COHORTS: Clinical tumor stage (per American Joint Committee on Cancer \[AJCC\] 8th edition): T1-4, N0-2a, M0. Patients who have a diagnosis of inflammatory breast cancer are eligible. Patients should not have clinical evidence of locoregional or distant metastatic breast cancer
- EARLY HER2+ BREAST CANCER COHORT: Have completed NST with a trastuzumab plus pertuzumab and chemotherapy-based regimen (for example, docetaxel plus minus carboplatin plus trastuzumab plus pertuzumab known as the docetaxel/pertuzumab/trastuzumab \[THP\]/carboplatin/paclitaxel/pertuzumab/trastuzumab \[TCHP\] regimens) followed by definitive breast surgery where the surgical pathology reports a pCR (ypT0-Tis, ypN0) and are willing to discontinue adjuvant trastuzumab plus pertuzumab
- EARLY TNBC COHORT: Have completed NST with a pembrolizumab plus chemotherapy-based regimen (for example, the KEYNOTE-522 regimen which is paclitaxel plus carboplatin plus pembrolizumab followed by doxorubicin plus cyclophosphamide plus pembrolizumab) followed by definitive breast surgery where the surgical pathology reports a pCR (ypT0-Tis, ypN0) and are willing to discontinue adjuvant pembrolizumab
- The surgical pathology report needs to show a pCR (ypT0-Tis, ypN0) for a patient to be able to participate in this study and all enrolled patients should be willing to discontinue standard adjuvant systemic therapy
- FOR BOTH HER2+ AND TNBC COHORTS: Adequate archival tumor tissue from the core diagnostic biopsy (per Personalis)
- FOR BOTH HER2+ AND TNBC COHORTS: Age ≥ 18 years
- FOR BOTH HER2+ AND TNBC COHORTS: Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
- FOR BOTH HER2+ AND TNBC COHORTS: Absolute neutrophil count ≥ 1,000/mcL
- FOR BOTH HER2+ AND TNBC COHORTS: Hemoglobin ≥ 9.0 g/dL
- FOR BOTH HER2+ AND TNBC COHORTS: Platelets ≥ 100,000/mcL
- FOR BOTH HER2+ AND TNBC COHORTS: Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN); patients with Gilbert's syndrome (if direct bilirubin <1.5 x institutional ULN)
- FOR BOTH HER2+ AND TNBC COHORTS: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 × institutional ULN
- FOR BOTH HER2+ AND TNBC COHORTS: Creatinine ≤ 1.5 mg/dL
- FOR BOTH HER2+ AND TNBC COHORTS: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- FOR BOTH HER2+ AND TNBC COHORTS: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- FOR BOTH HER2+ AND TNBC COHORTS: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible
- FOR BOTH HER2+ AND TNBC COHORTS: Pre- and postmenopausal women are eligible
- FOR BOTH HER2+ AND TNBC COHORTS: Ability to understand and the willingness to sign a written informed consent document
- Patients with tumor stage of cN2b or cN3 are not eligible
- History of other malignancies besides breast cancer within the past 5 years, except cervical cancer in situ, melanoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin
- Patients who are receiving any other anti-cancer investigational agents
- Patients with known cancer metastases from any site
- Patients with uncontrolled intercurrent illness including but not limited to active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrythmias
- Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Blood transfusion within 2 weeks before collection of blood for ctDNA testing
- Patients who have received 4 or more cycles of SOC adjuvant trastuzumab/pertuzumab (HER2+) or 4 or more cycles of SOC adjuvant pembrolizumab (TNBC)
- Pregnant women are not eligible to participate in this study
Centro de Câncer MD AndersonSem dados de contato.
1 Locais do estudo em 1 países
Texas
M D Anderson Cancer Center, Houston, Texas, 77030, United States