NCT02041338

Study of Optimizing Neoadjuvant Regimens in Subtypes of Breast Cancer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Neoadjuvant Chemotherapy

Interventions

Type	Name	Description
DRUG	Paclitaxel and carboplatin
DRUG	Paclitaxel
DRUG	Epirubicin and Paclitaxel

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2014-01-22
• Last updated: 2014-11-25

Locations

1 site across 1 country: China