Clinical trial NCT02980965: Neoadjuvant Chemo-endocrine Therapy Versus Chemotherapy Alone in ER-positive, HER2-negative Breast Cancer
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer Female
Keywords: breast cancer
neoadjuvant chemotherapy
endocrine therapy
concurrent
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 249
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: objective response rate (ORR)
timeFrame: 4 years
Secondary outcomes:
measure: Ki67 proliferation marker changes
timeFrame: 4 years
measure: pathologic complete response (pCR)
timeFrame: 4 years
measure: pathological response rate
timeFrame: 4 years
measure: Progression-free survival (DFS)
timeFrame: 6 years
measure: Incidence of Serious Treatment-Emergent Adverse Events(grade 3 or 4)
timeFrame: 4 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer Hospital/ Institute, Fudan University
state: Shanghai
Study officials:
affiliation: Cancer Hospital/ Institute, Fudan University
name: Zhi-Min Shao, MD
role: PRINCIPAL_INVESTIGATOR
References: