Twitter Facebook LinkedIn
Center for Global Research Data

Predictors of therapeutic and adverse effects of medicines used in the treatment of breast cancer

Lead Investigator: Ashley Hopkins, Flinders University
Title of Proposal Research: Predictors of therapeutic and adverse effects of medicines used in the treatment of breast cancer
Vivli Data Request: 5289, 5323
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Breast cancer is the most commonly occurring cancer in women and the second most common cancer overall. There were over 2 million new cases in 2018. There are many important medicines used in the treatment of breast cancer. However, response and toxicity to many therapies is highly unpredictable. For example, over half the eligible patients do not respond to anti-human epidermal growth factor receptor 2 (HER2) targeted therapy when used in the treatment of advanced breast cancer. Thus, more research is required to confirm and explore novel predictive markers of therapeutic and adverse effects of medicines used in the treatment of breast cancer.

Using the diverse range of data collected from clinical trials, it is possible to develop clinical tools that enable improved prediction of therapeutic and adverse outcomes of patients using medicines in the treatment of breast cancer. Being able to identify the expected response and adverse effect profile may enable patients and clinicians to make better decisions regarding whether to commence, continue, discontinue or change dosing of medicines used in the treatment of breast cancer.

Requested Studies:

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting
Sponsor: Eli Lilly and Company
Study ID: NCT02246621
Sponsor ID: 15417

MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
Sponsor: Eli Lilly and Company
Study ID: NCT02107703
Sponsor ID: 15362

A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
Sponsor: Eli Lilly and Company
Study ID: NCT02102490
Sponsor ID: 15419

(Note: Additional studies added as part of data request 5289)

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: NCT00721409

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer
Sponsor: Roche
Study ID: NCT01663727
Sponsor ID: GO25632

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
Sponsor: Roche
Study ID: NCT01419197
Sponsor ID: TDM4997g

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)
Sponsor: Roche
Study ID: NCT01401166
Sponsor ID: MO22982

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
Sponsor: Roche
Study ID: NCT01120184
Sponsor ID: BO22589

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)
Sponsor: Roche
Study ID: NCT00950300
Sponsor ID: BO22227

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
Sponsor: Roche
Study ID: NCT00829166
Sponsor ID: BO21977

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
Sponsor: Roche
Study ID: NCT00545688
Sponsor ID: WO20697

An International Multi-centre Open-label 2-arm Phase III Trial of Adjuvant Bevacizumab in “Triple Negative” Breast Cancer.
Sponsor: Roche
Study ID: NCT00528567
Sponsor ID: BO20289

A Randomized, Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Herceptin/Docetaxel and Herceptin/Docetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer.
Sponsor: Roche
Study ID: NCT00391092
Sponsor ID: BO20231

A Randomised, Double Blind, Placebo Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Docetaxel in Comparison With Docetaxel Plus Placebo, as First Line Treatment for Patients With HER2 Negative Metastatic and Locally Recurrent Breast Cancer.
Sponsor: Roche
Study ID: NCT00333775
Sponsor ID: BO17708

A Randomized, Open-label Study of the Effect of Adjuvant Therapy With Adriamycin Plus Cytoxan Followed by Taxotere or Taxotere Plus Xeloda on Overall Survival in Female Patients With High-risk Breast Cancer
Sponsor: Roche
Study ID: NCT00089479
Sponsor ID: NO17629

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
Sponsor: Roche
Study ID: NCT00045032
Sponsor ID: BO16348

LUX-Breast 1; An Open Label, Randomised Phase III Trial of BIBW 2992 and Vinorelbine Versus Trastuzumab and Vinorelbine in Patients With Metastatic HER2-overexpressing Breast Cancer Failing One Prior Trastuzumab Treatment
Sponsor: Boehringer Ingelheim
Study ID: NCT01125566
Sponsor ID: 1200.75

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
Sponsor: Roche
Study ID: NCT00567190
Sponsor ID: TOC4129g

A Phase III, Multicenter, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Treated Metastatic Breast Cancer
Sponsor: Roche
Study ID: NCT00281697
Sponsor ID: AVF3693g

A Multicenter, Phase III, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Untreated Metastatic Breast Cancer
Sponsor: Roche
Study ID: NCT00262067
Sponsor ID: AVF3694g

neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination With Anastrozole to Those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy With Abemaciclib in Combination With Anastrozole in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer
Sponsor: Eli Lilly and Company
Study ID: NCT02441946
Sponsor ID: 15805

An Exploratory Phase II, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Pertuzumab and Herceptin (Trastuzumab) in Patients With HER2-Positive Metastatic Breast Cancer
Sponsor: Roche
Study ID: NCT01674062
Sponsor ID: BO17929

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
Sponsor: Roche
Study ID: NCT00976989
Sponsor ID: BO22280

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
Sponsor: Roche
Study ID: NCT00679341
Sponsor ID: BO21976

A Phase II, Single-Arm, Open-Label Study of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer
Sponsor: Roche
Study ID: NCT00679211
Sponsor ID: TDM4374g

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
Sponsor: Roche
Study ID: NCT00509769
Sponsor ID: TDM4258g

Lux-Breast 3; Randomised Phase II Study of Afatinib Alone or in Combination With Vinorelbine Versus Investigator’s Choice of Treatment in Patients With HER2 Positive Breast Cancer With Progressive Brain Metastases After Trastuzumab and/or Lapatinib Based Therapy
Sponsor: Boehringer Ingelheim
Study ID: NCT01441596
Sponsor ID: 1200.67

Chemotherapy and Antibody Response Evaluation (CARE): A phase III, multinational, randomized study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) combined with chemotherapy in patients with HER2 overexpression who have not received cytotoxic chemotherapy for metastatic breast cancer.
Sponsor: Roche
Sponsor ID: H0648G

An open-label extension study with recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) for patients whose metastatic breast cancer progressed during treatment on protocol H0648g.
Sponsor: Roche
Sponsor ID: H0659G

A multinational open-label study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2lneu overexpression who have relapsed following one or two cytotoxic chemotherapy regimens for metastatic breast cancer.
Sponsor: Roche
Sponsor ID: H0649G

A multinational randomized single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2lneu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer.
Sponsor: Roche
Sponsor ID: H0650G

A multicenter, expanded access, open-label safety study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2 overexpression who relapsed following multiple cytotoxic chemotherapy regimens for metastatic breast cancer.
Sponsor: Roche
Sponsor ID: H0693G

A Multicenter, Randomized Comparative Study on the Efficacy and Safety of Herceptin (Trastuzumab) Plus Docetaxel (Taxotere) Versus Docetaxel Alone as First Line Treatment in Patients with HER2-Positive Metastatic Breast Cancer
Sponsor: Roche
Sponsor ID: M77001

An open-label, randomized phase II study of Herceptin (trastuzumab), Taxotere (docetaxel) and Xeloda (capecitabine) in combination, versus Herceptin (trastuzumab) plus Taxotere (docetaxel), in patients with advanced and/or metastatic breast cancers that overexpress HER2.
Sponsor: Roche
Sponsor ID: MO16419

A Multicenter, Open-Label, Phase III, Randomized, Active-Controlled Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of rhuMAb VEGF (Bevacizumab), in Combination With Capecitabine Chemotherapy, in Subjects With Previously Treated Metastatic Breast Cancer
Sponsor: Roche
Study ID: NCT00109239
Sponsor ID: AVF2119g

A Randomized, Open-label Study of the Effect of Herceptin Plus Arimidex Compared With Arimidex Alone on Progression-free Survival in Patients With HER2-positive and Hormone-receptor Positive Metastatic Breast Cancer
Sponsor: Roche
Study ID: NCT00022672
Sponsor ID: BO16216

Phase III Study of Gemcitabine Plus Paclitaxel Versus Paclitaxel in Patients With Unresectable, Locally Recurrent or Metastatic Breast Cancer
Sponsor: Eli Lilly and Company
Study ID: NCT00006459
Sponsor ID: 2017

monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician’s Choice Plus Trastuzumab in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
Sponsor: Eli Lilly and Company
Study ID: NCT02675231
Sponsor ID: 15804

A Phase II Randomized, Double-Blind Study of Neoadjuvant Letrozole Plus GDC-0032 Versus Letrozole Plus Placebo in Postmenopausal Women With ER-positive/HER2-negative, Early Stage Breast Cancer
Sponsor: Roche
Study ID: NCT02273973
Sponsor ID: GO28888

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
Sponsor: Roche
Study ID: NCT01566721
Sponsor ID: MO28048

A Phase III Randomized Study Evaluating the Efficacy and Safety of Continued and Re-induced Bevacizumab in Combination With Chemotherapy for Patients With Locally Recurrent or Metastatic Breast Cancer After First-line Chemotherapy and Bevacizumab Treatment
Sponsor: Roche
Study ID: NCT01250379
Sponsor ID: MO22998

A Multicenter, Multinational, Randomized, Double-Blind, Phase III Study of IMC-1121B Plus Docetaxel Versus Placebo Plus Docetaxel in Previously Untreated Patients With HER2-Negative, Unresectable, Locally-Recurrent or Metastatic Breast Cancer
Sponsor: Eli Lilly and Company
Study ID: NCT00703326
Sponsor ID: 13892

An Open-label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer
Sponsor: Roche
Study ID: NCT00448591
Sponsor ID: MO19391