Clinical and molecular characteristics of human epidermal growth factor receptor 2-positive breast cancers: a meta-analysis

Lead Investigator: Hongmei Zheng, Huazhong University of Science and Technology
Title of Proposal Research: Clinical and molecular characteristics of human epidermal growth factor receptor 2-positive breast cancers: a meta-analysis
Vivli Data Request: 9787
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Breast cancer is the most common malignancy in women worldwide. One type of breast cancer called human epidermal growth factor receptor 2-positive (HER2+) breast cancer accounts for almost 40% of them, it is an aggressive cancer with a poor prognosis.
A patient with HER2-positive breast cancer tests positive for a protein called human epidermal growth factor receptor 2. The cancer cells have extra copies of the gene that makes the protein, and the protein promotes the growth of cancer cells.

Breast cancer cells may also have proteins on their surface called hormone receptors. Whether these are present or not determines if the cancer is hormone receptor positive (HR+) or negative (HR-).

Currently, therapy for the disease is greatly improving survival outcomes in this group of patients, however, there are still many unmet needs, such as differences in the efficacy of neoadjuvant therapy in patients with HR+/HER2+ cancer versus those with HR-/HER2+ cancer. Neoadjuvant therapy is a drug treatment given to the patient before their main treatment which may for example be surgery. The aim of neoadjuvant therapy is to shrink the tumor.

HR+/HER2+ patients exhibit distinct biological characteristics and responds less favorably to conventional neoadjuvant therapy in comparison to HR-/HER2+ patients. Thus, we want to deeply explore the differences in the data collected from these patients such as response rates and prognosis through an of a large number of similar clinical studies in Vivli database. Finally, we can treat these two subtypes of breast cancer patients with different and specified methods and provide the new basis for the classification of HER2+ breast cancer patients, so as to find the potential mechanism and the precision treatment strategy for these two different subtypes of HER2+ breast cancer patients.

Requested Studies:

A Randomized, Open Label Study to Compare the Complete Pathological Response Rate Achieved With 4 Combinations of Herceptin, Docetaxel and Pertuzumab in Patients With Locally Advanced, Inflammatory or Early Stage HER2 Positive Breast Cancer
Data Contributor: Roche
Study ID: NCT00545688
Sponsor ID: WO20697

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate Pertuzumab in Combination With Docetaxel and Trastuzumab as Neoadjuvant Therapy, and Pertuzumab in Combination With Trastuzumab as Adjuvant Therapy After Surgery and Chemotherapy in Patients With Early-Stage or Locally Advanced HER2-Positive Breast Cancer
Data Contributor: Roche
Study ID: NCT02586025
Sponsor ID: YO28762

A Randomised, Multicentre, Multinational Phase II Study to Evaluate Pertuzumab in Combination With Trastuzumab, Given Either Concomitantly or Sequentially With Standard Anthracycline-based Chemotherapy or Concomitantly With a Non-anthracycline-based Chemotherapy Regimen, as Neoadjuvant Therapy for Patients With Locally Advanced, Inflammatory or Early Stage HER2-positive Breast Cancer
Data Contributor: Roche
Study ID: NCT00976989
Sponsor ID: BO22280

A Multicenter, Multinational, Phase II Study to Evaluate Perjeta in Combination With Herceptin and Standard Neoadjuvant Anthracycline-Based Chemotherapy in Patients With HER2-Positive, Locally Advanced, Inflammatory, or Early-Stage Breast Cancer
Data Contributor: Roche
Study ID: NCT02132949
Sponsor ID: WO29217

A Randomized, Multicenter, Open-Label, Two-Arm, Phase III Neoadjuvant Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Patients With HER2-Positive Breast Cancer
Data Contributor: Roche
Study ID: NCT02131064
Sponsor ID: BO28408

A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Data Contributor: Roche
Study ID: NCT01358877
Sponsor ID: BO25126

A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy
Data Contributor: Roche
Study ID: NCT01772472
Sponsor ID: BO27938

A Randomized Three-Arm, Multicenter Comparison of 1 Year and 2 Years of Herceptin Versus No Herceptin in Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy
Data Contributor: Roche
Study ID: NCT00045032
Sponsor ID: BO16348

A Phase III, Randomized Open-Label Study to Compare the Pharmacokinetics, Efficacy, and Safety of Subcutaneous (SC) Trastuzumab With Intravenous (IV) Trastuzumab Administered in Women With HER2-Positive Early Breast Cancer (EBC)
Data Contributor: Roche
Study ID: NCT00950300
Sponsor ID: BO22227

A Randomized, Multi-Center Cross-Over Study to Evaluate Patient Preference and Health Care Professional (HCP) Satisfaction With Subcutaneous (SC) Administration of Trastuzumab in HER2-Positive Early Breast Cancer (EBC)
Data Contributor: Roche
Study ID: NCT01401166
Sponsor ID: MO22982

A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer
Data Contributor: Roche
Study ID: NCT01566721
Sponsor ID: MO28048