Study of Optimizing Neoadjuvant Regimens in Subtypes of Breast Cancer

Breast Cancer Clinical Trial

Official title:

Phase 2 Randomized Study of Different Neoadjuvant Regimens in Subtypes of Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02041338
• Other study ID #: CH-BC-026
• Status: Recruiting
• Phase: Phase 2
• First received: January 15, 2014
• Last updated: November 24, 2014
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: February 2014
• Source: Chinese Academy of Medical Sciences
• Contact: Ying Fan, MD
• Phone: 861087788114
• Email: fanyingfy[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neoadjuvant Chemotherapy

Intervention

Drug:
• Paclitaxel and carboplatin

• Paclitaxel

• Epirubicin and Paclitaxel

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological complete response(pCR) rate of breast and axilla after surgery	pathological complete response(pCR) of breast and axilla after surgery means after operation, no invasive component can be found in both breast and axillary lymph nodes. The pCR rate is calculated by number of patients having pCR after sugery divided by number of patients receiving neoadjuvant chemotherapy.	3 years	No
Secondary	Disease free survival		3years and 5years after operation	No
Secondary	Overall survival		3 years and 5years after operation	No
Secondary	Adverse event		during screening and treatment, withing 21 days after day 1 of last cycle	Yes