Neoadjuvant Chemo-endocrine Therapy Versus Chemotherapy Alone in ER-positive, HER2-negative Breast Cancer

A Randomized Controlled Study to Evaluate the Efficacy and Safety of Endocrine Therapy Plus Chemotherapy Versus Chemotherapy Alone as the Neoadjuvant Therapy in the Treatment of ER-positive, HER2-negative Breast Cancer (IIa-IIIc)

Patrocinadores

Patrocinador principal: Fudan University

Fuente Fudan University
Resumen breve

This was an open-label, randomized controlled trial that aims to compare the efficacy and safety of the concurrent neoadjuvant chemotherapy with endocrine therapy and neoadjuvant chemotherapy alone in ER-positive, HER2-negative breast cancer.

Descripción detallada

Data showed that concurrent neoadjuvant chemotherapy with endocrine therapy was a effective option for ER-positive, HER2-negative breast cancer patients. However this is still a controversial issue. The present study is an open-label randomized controlled clinical trial that aims to investigate the efficacy of concurrent NCT with endocrine therapy (AI with or without GnRH-a) in patients with ER-positive, HER2-negative breast carcinoma.

Estado general Completed
Fecha de inicio May 2013
Fecha de Terminación February 2017
Fecha de finalización primaria February 2017
Fase Phase 3
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
objective response rate (ORR) 4 years
Resultado secundario
Medida Periodo de tiempo
Ki67 proliferation marker changes 4 years
pathologic complete response (pCR) 4 years
pathological response rate 4 years
Progression-free survival (DFS) 6 years
Incidence of Serious Treatment-Emergent Adverse Events(grade 3 or 4) 4 years
Inscripción 249
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxel

Descripción: Postmenopausal patients were treated with letrozole 2.5mg/day p.o until complement of neoadjuvant chemotherapy before surgery, while premenopausal ones received letrozole 2.5mg/day p.o and a subcutaneous injection of the GnRH-a, leuprorelin, as concomitant treatment with neoadjuvant chemotherapy (fluorouracil 600mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 80mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles), letrozole was delivered after 1 week of first dose of leuprorelin injection.

Etiqueta de grupo de brazo: neoadjuvant chemo-endocrine therapy

Otro nombre: GnRH-a, ENANTONE

Tipo de intervención: Drug

Nombre de intervención: fluorouracil, epirubicin, cyclophosphamide, docetaxel

Descripción: Patients received fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles.

Etiqueta de grupo de brazo: neoadjuvant chemotherapy alone

Elegibilidad

Criterios:

Inclusion Criteria:

1. Estrogen receptor-positive and HER2-negative breast cancer patients, with histological stage of IIa-IIIc.

2. Without previous chemotherapy or endocrine therapy.

3. ECOG scores of 0-2 points

4. With measurable and evaluable breast tumor pathologically confirmed as invasive ductal carcinoma

5. Age: 18-70 years

6. Lateral breast cancer

7. Normal or acceptable kidney, liver, cardiovascular, and bone marrow functions

Exclusion Criteria:

1. Pregnant women or nursing mothers

2. With distant metastasis

3. With a history of malignant tumor or complicated with other malignant tumors in addition to breast cancer, except for non-melanoma skin cancer, in situ cervical cancer or other cured malignant tumor without the basis of recurrence for at least five years

4. With mental illness or other conditions affecting the patient compliance

5. With other serious diseases or medical conditions:

1. Congestive heart failure or unstable angina pectoris, myocardial infarction within 6 months before the enrollment, uncontrolled hypertension and uncontrolled high-risk arrhythmia considered by the investigator

2. Obvious neurological or psychiatric disorders, including psychosis, epileptic dementia and other diseases may affect the understanding and sign of the informed consent for

3. Uncontrolled acute infection

6. Concurrent use of other investigational drugs; or participating in other clinical trials involving investigational drugs within 30 days before this study

7. With allergic constitution and any known or suspected drug allergy

8. Not suitable for the trial considered by the investigator

Género: Female

Edad mínima: 18 Years

Edad máxima: 70 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Zhi-Min Shao, MD Principal Investigator Cancer Hospital/ Institute, Fudan University
Ubicación
Instalaciones: Cancer Hospital/ Institute, Fudan University
Ubicacion Paises

China

Fecha de verificación

November 2017

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Fudan University

Nombre completo del investigador: Zhimin Shao

Título del investigador: Director of Department of Surgical Oncology,Cancer Hospital & Institute

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: neoadjuvant chemo-endocrine therapy

Tipo: Experimental

Descripción: In the experimental arm, patients received concurrent chemotherapy (fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles) with endocrine therapy (letrozole with or without leuprorelin) as a neoadjuvant treatment

Etiqueta: neoadjuvant chemotherapy alone

Tipo: Active Comparator

Descripción: In the control group, patients received neoadjuvant chemotherapy alone (fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles)

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov