NCT03858322

'ADVANCE' (A Pilot Trial)

'ADVANCE' (A Pilot Trial) ADjuVANt Chemotherapy in the Elderly: Developing and Evaluating Lower-Toxicity Chemotherapy Options for Older Patients With Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to carefully study how chemotherapy is tolerated in group of patients age 70.

Detailed description

This clinical trial is dedicated to patients age 70 and older and is focused on understanding how the investigators can improve upon breast cancer outcomes for older women, a group of patients who often do worse than younger patients and who are not well represented in clinical trials to date. Through this clinical trial, the investigators aim to better understand the side effects, experiences, and changes in physical function that may occur with chemotherapy. The investigators are also very interested in the genomics (or gene-changes) and biological changes that may occur in breast cancers in older women that may be different from the changes we see in younger patients. Even though the chemotherapy agents being used in this study are used frequently when treating breast cancer, The investigators have limited information on how these agents are tolerated in older patients. This research study is called a Feasibility Study, because the investigators will be closely monitoring how easily it is to administer chemotherapy to a relatively small group of participants (up to 40) and to what degree side effects occur. The investigators will administer commercially available chemotherapy agents used in breast cancer in the specific setting of the treating older patients with early-stage breast cancer and with some mild modification of how these agents are given and in what combination. For participants with triple negative breast cancer, paclitaxel and carboplatin will be administered in standard, weekly doses. Both agents are FDA-approved for use in early breast cancer. However, carboplatin and paclitaxel are not typically used as a 'stand-alone' treatment for breast cancer, meaning they are often used together along with other chemotherapy agent(s) over a longer period. For participants with hormone receptor-positive breast cancer, paclitaxel and cyclophosphamide will be administered, which are both FDA-approved agents to treat breast cancer as part of a longer regimen to treat early breast cancer. In this clinical trial the investigators are modifying the way the chemotherapy is delivered so that it may be more tolerable than the longer treatment course. This clinical trial does not limit the use of other chemotherapy or other treatments being recommended for breast cancer, but any other recommended treatments would be given after the participants receive their paclitaxel and carboplatin on the clinical trial.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	The drug work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die.
DRUG	Cyclophosphamide	The drug work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die.
DRUG	Carboplatin	The drug work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die.

Timeline

• Start date: 2019-03-21
• Primary completion: 2020-11-10
• Completion: 2026-06-30
• First posted: 2019-02-28
• Last updated: 2025-08-11

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study