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

Fudan University

Status and phase: Completed; Phase 3

Conditions: Breast Cancer Female

Treatments: Drug: fluorouracil, epirubicin, cyclophosphamide, docetaxel; Drug: letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT02980965

NCET-trial

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 249 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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249 participants in 2 patient groups

neoadjuvant chemo-endocrine therapy

Experimental group

Description:

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

Treatment:

Drug: letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxel

neoadjuvant chemotherapy alone

Active Comparator group

Description:

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)

Treatment:

Drug: fluorouracil, epirubicin, cyclophosphamide, docetaxel