Lead Investigator: Sheng Luo, Duke University
Title of Proposal Research: Clinical and molecular characteristics of hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer a meta-analysis
Vivli Data Request: 8842
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Breast cancer (BC), constituting the highest cancer incidence in women, seriously threatens women’s health. Some breast cancer cells have a higher-than-normal level of a protein called HER2 (human epidermal growth factor receptor 2) on their surface, which stimulates them to grow. This is known as HER2 positive (HER2+) breast cancer. The identification of this protein in patients with breast cancer has made it possible to tailor cancer treatment to the individual patient.
Patients with lower than normal levels of HER2 protein in their cancer cells are classified as having HER2-negative breast cancer, which accounts for 30-40% of breast cancer patients. These patients are less likely to benefit from conventional monoclonal antibody (mAbs) treatments that target HER2. mAbs attach to the HER2 protein on cancer cells, which can help stop the cells from growing. HER2-negative breast cancers are often hormone receptor positive (HR+), meaning that they have receptors on the cells for the hormones estrogen (ER) or progesterone (PR). Hormone/endocrine therapy (ET) is the first treatment for women with HR+ and HER2-negative advanced breast cancer. Signals between HR and HER2 proteins are thought to contribute to resistance of these cancers to hormone therapy. ET-resistant patients are those who experience a relapse within 2 years of endocrine treatment or disease progression during the first 6 months of first-line endocrine therapy.
Previous clinical studies have shown that raised HER2 levels lead to lower overall response rate (ORR) and a worse prognosis for breast cancer patients treated with ET; however, this remains controversial. This study aims to evaluate the relationship between ET status and clinical outcomes in HR+/HER2- BC patients receiving hormone therapy and will hopefully help clinicians select personalized treatment strategies for HR+/HER2- breast cancer patients.
Requested Studies:
A Phase III, Double-Blind, Placebo-Controlled, Randomized Study of Taselisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
Data Contributor: Roche
Study ID: NCT02340221
Sponsor ID: GO29058
MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 TRIAL OF FULVESTRANT (FASLODEX (REGISTERED)). WITH OR WITHOUT PD-0332991 (PALBOCICLIB) +/- GOSERELIN IN WOMEN WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE THERAPY
Data Contributor: Pfizer Inc.
Study ID: NCT01942135
Sponsor ID: A5481023
PHASE 1/2, OPEN-LABEL, RANDOMIZED STUDY OF THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF LETROZOLE PLUS PD 0332991 (ORAL CDK 4/6 INHIBITOR) AND LETROZOLE SINGLE AGENT FOR THE FIRST-LINE TREATMENT OF ER POSITIVE, HER2 NEGATIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN
Data Contributor: Pfizer Inc.
Study ID: NCT00721409
Sponsor ID: A5481003
Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
Data Contributor: AstraZeneca
Study ID: NCT00313170
Sponsor ID: D6997C00006
Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
Data Contributor: AstraZeneca
Study ID: NCT00305448
Sponsor ID: D6997C00004
A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE
Data Contributor: Pfizer Inc.
Study ID: NCT01740427
Sponsor ID: A5481008