Research and Clinical Trials for Older Adults with Breast Cancer

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Our program brings together researchers and physicians dedicated to improving our understanding of breast cancer in older adults. In addition to clinical trials for patients of all ages, we offer many clinical trials dedicated to older patients designed to uncover new details about how breast cancer is different in older people. In these trials, we focus on issues that have been under-addressed in this age group. Clinicians and researchers are optimistic that this work may help develop more effective, personalized care, guiding older patients through the challenges of diagnosis, treatment, and survivorship.

Should you participate in a clinical trial?

Participating in a clinical trial is a very personal decision, and a choice that is completely yours to make. If it feels right to you, there are several good reasons to participate:

  • Clinical trials are how we make progress against cancer.
  • Taking part in a clinical trial can offer you new treatment options.
  • By participating in a clinical trial, you contribute to knowledge that can help future patients.

Speak to your doctor about your clinical trial options. Learn more about clinical trials and whether participating in a clinical trial is right for you.

Research Advances

A study by the Cancer and Aging Research Group, co-authored by Rachel A. Freedman, MD, MPH, resulted in a new tool to help predict which older breast cancer patients who are about to begin chemotherapy are likely to experience severe side effects. This work confirmed that understanding patients' overall health can help predict who may have more side effects, enabling physicians to better support these patients. Dr. Freedman has also examined patterns of care and survival for older patients with breast cancer and is committed to improving upon what we know about this disease.

Clinical Trials for Older Adults With Breast Cancer

Older adults are under-represented in breast cancer research, but physician scientists at Dana-Farber are committed to investigating new ways to improve treatment options and treatment outcomes for this population.

Featured Clinical Trials That Are Actively Enrolling

Although older patients can participate in almost any clinical trial, the following clinical trials at Dana-Farber are dedicated to this group of patients. If you are interested in learning more about them, ask your provider if these clinical trials may be right for you.

  • Abemaciclib and Endocrine Therapy in Older Patients with Metastatic Breast Cancer Identifier: NCT04305834
    This Phase IIA Trial assesses the tolerability and side effects of abemaciclib plus endocrine therapy in adults aged 70 or older with HR+/HER2- metastatic breast cancer who have progressed on prior CDK inhibitor. 
  • Improving Outcomes for Older Patients with Breast Cancer (Elevate) Identifier: NCT03818087
    Study team email:
    The Elevate study is a survey-based study which will follow patients for 5-10 years. This study aims to improve the care of older adults with breast cancer by assessing individualized treatment recommendations, reasons for treatment decisions, barriers to care, and outcomes in older patients. 

Clinical Trials That Are No Longer Enrolling; Results Are Forthcoming

The following clinical trials dedicated to older adults with breast cancer have recently completed enrollment. After a clinical trial closes, the outcome is carefully analyzed and physician-researchers seek to determine how the results of the trial may impact patient care in the future. While these clinical trials are not currently open to new patients, what we learn from these trials will help advance the care of older patients with breast cancer.

  • Lower-Toxicity Chemotherapy Options for Older Patients with Breast Cancer (Advance) Identifier: NCT03858322
    The Advance study evaluates the feasibility of two different, modified chemotherapy options for patients age 70 and older whose doctors have recommended they receive either neoadjuvant (pre-operative) or adjuvant (postoperative) chemotherapy for their cancers. The study examines the use of carboplatin-paclitaxel in patients with triple negative breast cancer and cyclophosphamide-paclitaxel in patients with hormone receptor-positive breast cancer and will focus on the side effects and functional status of patients receiving chemotherapy.
  • Adjuvant T-DM1 in Older Patients (ATOP) Identifier: NCT03587740
    The ATOP study evaluates the effectiveness and safety of the antibody drug conjugate T-DM1 (Kadcyla®), as well as its effect on quality of life, in older adults with HER2-positive breast cancer.
  • Individualizing Surveillance Mammography for Older Breast Cancer Survivors Identifier: NCT03865654
    This study examines clinician and patient attitudes toward surveillance mammography and follow-up for older breast cancer survivors with the aim to improve communication between clinicians and patients.
  • Palbociclib and Fulvestrant or Letrozole in Metastatic Breast Cancer (Alliance) Identifier: NCT03633331
    This study evaluates a commonly used treatment in metastatic cancer – the combination of targeted therapy palbociclib (Ibrance®) with hormone therapy letrozole (Femara®) or fulvestrant (Faslodex®) – to better understand how patients age 70 or older with estrogen receptor-positive, HER2-negative metastatic breast cancer feel while taking this medication.
  • Tesetaxel for Patients age 65 and Older with Metastatic Breast Cancer (CONTESSA TRIO) Identifier: NCT03952325
    This study is evaluating how well a new oral chemotherapy works against metastatic breast cancer. One part of this study focused on patients 65 and older, who were given this investigational medication on its own. Other parts of the study are also looking at ways of combining this new chemotherapy with immunotherapy medications.

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