Clinical trial NCT02041338: Study of Optimizing Neoadjuvant Regimens in Subtypes of Breast Cancer
Official title: Phase 2 Randomized Study of Different Neoadjuvant Regimens in Subtypes of Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Neoadjuvant Chemotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2014-01-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are no standard neodjuvant regimens adapted according to the different subtypes of breast cancer. This is a phase 2, randomized study to evaluate several regimens in different subtypes of breast cancer.

Detailed description: Breast cancer is a heterogenous disease with at least 4 intrinsic subtypes including Luminal A, Luminal B, HER2 enriched, Basal-like and normal breast like. Different subtypes have different prognosis and treatment sensitivity. Thus, it would be more suitable to administer different chemo-regimen in different subtypes. This is especially true in neoadjuvant chemotherapy setting where no standard regimen has ever been established. Therefore, we designed this phase 2 randomized clinical trial to explore potential effective regimens in variable subtypes of breast cancer in neoadjuvant treatment. Patients were first classified into Luminal type, Her2 positive type and triple-negative type by immunohistochemistry exam of ER/PR/HER2 in core needle biopsy and then randomized to received either dose dense paclitaxel in Luminal type or dose dense paclitaxel plus carboplatin with or without trastuzumab in HER2 positive type or dose dense paclitaxel plus carboplatin in triple-negative type.The control groups in each subtype all receive paclitaxel plus epirubicin every 3 weeks. The duration of treatment is 4-6 cycles. Primary endpoint is the pathological CR rate in each subtypes. Secondary endpoints include disease free survival, objective response rate, safety. Tissue samples and blood samples will be collected at baseline and during treatment. There will be exploratory biomarkers analyses to identify predictive markers for efficacy in every subtypes.

Eligibility criteria: Inclusion Criteria:

* Stage IIa-IIIc breast cancer patients plan to receive neoadjuvant chemotherapy
* Patients have enough tissue sample to do IHC test for subtype classification
* Patients have at least one measurable lesion according to RECIST1.1
* KPS≥80
* No prior treatment for breast cancer
* Adequate bone marrow (neutrophil count ≥1500 ml and platelet count ≥100,000 ml), renal (serum creatinine \<1.5 times the upper limit of normal \[ULN\] or a creatinine clearance of ≥60 ml/minute), hepatic (total bilirubin ≤1.5 ULN; alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase ≤2.5 ULN), and cardiac function (assessed by electrocardiogram or thoracic radiography) were required.

Exclusion Criteria:

* Fertile women were excluded if pregnant or lactating or if they were not using adequate contraception.
* Previous chemotherapy for breast cancer.
* history of other serious illness (e.g. congestive heart failure, angina pectoris, uncontrolled hypertension or arrhythmia, clinically significant neurologic or psychiatric disorders, uncontrolled serious infection, AIDS), had an organ allograft, severe gastrointestinal disorder, or other neoplasias (except for in situ cervical cancer, non-melanoma skin cancer, or previous diagnosis of cancer with no evidence of disease for \>10 years).

Primary outcomes:
measure: pathological complete response(pCR) rate of breast and axilla after surgery
timeFrame: 3 years
Secondary outcomes:
measure: Disease free survival
timeFrame: 3years and 5years after operation
measure: Overall survival
timeFrame: 3 years and 5years after operation
measure: Adverse event
timeFrame: during screening and treatment, withing 21 days after day 1 of last cycle
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Binghe Xu, MD
role: PRINCIPAL_INVESTIGATOR
References: