Lead Investigator: Wenjun Yi, The Second Xiangya Hospital of Central South University
Title of Proposal Research: Assessing the Efficacy of Trastuzumab Emtansine (T-DM1) in Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer Across Varying Hormone Receptor Statuses
Vivli Data Request: 9764
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Breast cancer is the most common type of cancer found in women. In 2022, about 290,560 women in China were expected to be diagnosed with breast cancer, and sadly, about 43,780 might have passed away from it.
Breast cancer can be different in each person. One way doctors understand these differences is by looking at certain proteins and receptors in the cancer cells. Two important ones are called Human Epidermal Growth Factor Receptor 2 (HER2) and hormone receptors (HR).
Let’s break these down:
HER2: This is a protein that can make cancer cells grow quickly. Some breast cancers have a lot of HER2 – we call these “HER2-positive.”
Hormone receptors: These are like docking stations on cancer cells where hormones like estrogen can attach. If a cancer has these, it’s called “estrogen receptor-positive.”
Estrogen regulates the growth, development, and physiology of the human reproductive system. It acts as a catalyst for cancer growth because it stimulates the division and proliferation of breast tissue, a process that carries the risk for cancer-causing mutations.
About 20% of advanced breast cancers have a lot of HER2, and over 70% have estrogen receptors. Stopping estrogen from helping these cancers grow has been an important treatment for a long time.
Since 2013, a special kind of medicine called trastuzumab emtansine (T-DM1) has been used for HER2-positive cancers. T-DM1 is a kind of antibody-drug conjugate (ADC). This means it combines an antibody (a protein that can find and stick to HER2) with a drug that can kill cancer cells. It’s like a smart missile that finds and destroys only the cancer cells.
Interestingly, not all HER2-positive breast cancers respond the same way to treatments, especially if they also have estrogen receptors. We’ve noticed that cancers with both HER2 and estrogen receptors might need different treatments than those with just HER2.
This study looked at women with advanced breast cancer who have a lot of HER2. It checked if their cancer also had estrogen receptors and how they responded to T-DM1 treatment. The results could help doctors decide if they should treat HER2-positive/estrogen receptor-positive breast cancers as a special kind, which might need different medicines.
In simple terms, this research is really important because it helps doctors understand how to better treat different types of breast cancer. It could lead to better care for patients and even save more lives in the future.
Requested Studies:
A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and Safety of Trastuzumab MCC-DM1 vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy
Data Contributor: Roche
Study ID: NCT00829166
Sponsor ID: BO21977
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab and Taxane Based Therapy
Data Contributor: Roche
Study ID: NCT02924883
Sponsor ID: WO30085
A Phase III Randomized, Multicenter, Two Arm, Open-label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician’s Choice in Patients With HER2-positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2 Directed Therapy
Data Contributor: Roche
Study ID: NCT01419197
Sponsor ID: BO25734
A Randomized, Multicenter, Phase ii Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease
Data Contributor: Roche
Study ID: NCT00679341
Sponsor ID: BO21976
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, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer
Data Contributor: Roche
Study ID: NCT01120184
Sponsor ID: BO22589
A Phase II, Single-Arm, Open-Label Study of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer
Data Contributor: Roche
Study ID: NCT00679211
Sponsor ID: TDM4374g
A Two-Cohort, Open-Label, Multicenter Study of Trastuzumab Emtansine (T-DM1) in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients Who Have Received Prior Anti-HER2 and Chemotherapy-Based Treatment
Data Contributor: Roche
Study ID: NCT01702571
Sponsor ID: MO28231
A Phase II, Open-Label Study to Evaluate Corrected QT Interval Effects of Trastuzumab-MCC-DM1 (T-DM1) in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer and to Evaluate the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients With Early Disease Progression While Receiving T-DM1 Alone
Data Contributor: Roche
Study ID: NCT00943670
Sponsor ID: TDM4688g
A Phase II, Single-arm, Open-label Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed While Receiving HER2-Directed Therapy
Data Contributor: Roche
Study ID: NCT00509769
Sponsor ID: TDM4258g
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
An Open-Label, Multi-Center Phase I/II Study of the Safety and Tolerability of the Combination of Trastuzumab-MCC-DM1 (T-DM1) With Docetaxel, and Potentially Pertuzumab, for Treatment for Patients With Advanced Breast Cancer
Data Contributor: Roche
Study ID: NCT00934856
Sponsor ID: BP22572