Health-Related Quality of Life in Breast Cancer Clinical Trials Through the Lens of Race and Ethnicity: The Importance of Understanding the Patient Experience

Lead Investigator: Erinne Wasalski, Rutgers University
Title of Proposal Research: Health-Related Quality of Life in Breast Cancer Clinical Trials Through the Lens of Race and Ethnicity: The Importance of Understanding the Patient Experience
Vivli Data Request: 9230
Funding Source: None
Potential Conflicts of Interest: I am an employee of Daiichi Sankyo. Daiichi Sankyo is not involved in or funding my research and is being conducted independently of my employment in fulfillment of the requirements for the PhD degree through Rutgers University. This will be disclosed within my dissertation and upon publication of any manuscripts.

Summary of the Proposed Research:

Breast cancer is a disease characterized by the abnormal growth of cells in breast tissue. It is a significant global health concern, particularly among women. By the end of 2020, it had become the most common cancer in women worldwide, with over 7 million new diagnoses in the past five years. This prevalence is not uniform, as breast cancer rates and outcomes vary among different regions and ethnic groups.

Recognizing the diversity in how breast cancer affects individuals, personalized patient-centered care is crucial. This approach tailors medical decisions and support to the specific needs, preferences, and values of each patient. By doing so, it enhances communication, engagement, and overall outcomes while addressing the holistic well-being of the patient.

As advancements in treatment options increase life expectancy for breast cancer patients, the concept of Health-Related Quality of Life (HRQoL) has gained prominence. HRQoL takes into account the broader impact of cancer and its treatments on a patient’s well-being. Understanding HRQoL is vital for patient-centered care, but challenges persist in meeting the diverse needs of different patient populations.

While previous studies have focused on breast cancer survivors, they haven’t thoroughly explored HRQoL differences across demographic sub-groups in clinical trials. Additionally, clinical guidance provided by organizations like the National Comprehensive Cancer Network (NCCN) often lacks HRQoL data, which could better inform both patients and clinicians.

This new study aims to address these gaps by conducting a meta-analysis of data from multiple breast cancer clinical trials. It will specifically examine HRQoL data collected using tools like European Organisation for Research and Treatment of Cancer (EORTC) European or Functional Assessment of Cancer Therapy (FACT), questionnaires that are completed by patients about their physical, psychological and social functions. Patients will be grouped based on demographics, including race, ethnicity, and global location. By doing so, the study seeks to identify and describe any differences in HRQoL among these sub-groups and compare them to the overall population. This information can help refine treatment approaches and contribute to more inclusive research in the future.

Moreover, the study objective is that the findings could be integrated into patient-physician discussions and clinical guidelines, promoting the idea that clinical research should be an extension of cancer care. In summary, this research aims to shed light on the relationship between HRQoL, health equity, and breast cancer treatment, ultimately working towards better outcomes for all patients.

Requested Studies:

A PHASE 3, OPEN-LABEL, RANDOMIZED PARALLEL,2-ARM,MULTI-CENTER STUDY OF TALAZOPARIB(BMN 673) VERSUS PHYSICIAN’S CHOICE IN GERMLINE BRCA MUTATION SUBJECTS WITH LOCALLY ADVANCED AND/OR METASTATIC BREAST CANCER, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY REGIMENS FOR METASTATIC DISEASE
Data Contributor: Pfizer Inc.
Study ID: NCT01945775
Sponsor ID: 673-301

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
Data Contributor: Roche
Study ID: NCT01250379
Sponsor ID: MO22998

A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Data Contributor: Roche
Study ID: NCT01966471
Sponsor ID: BO28407

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

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 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, Two-Arm, Open-Label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab Plus an Aromatase Inhibitor in First Line Patients With HER2-Positive and Hormone Receptor-Positive Advanced (Metastatic or Locally Advanced) Breast Cancer
Data Contributor: Roche
Study ID: NCT01491737
Sponsor ID: MO27775

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
Data Contributor: Lilly
Study ID: NCT02441946
Sponsor ID: 15805

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

A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer
Data Contributor: Roche
Study ID: NCT01572038
Sponsor ID: MO28047

A Randomized, Multicenter, Open-Label Cross-Over Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Patients With HER2-Positive Early Breast Cancer
Data Contributor: Roche
Study ID: NCT03674112
Sponsor ID: MO40628