Can a softer chemo regimen spare older breast cancer patients?
NCT ID NCT03858322
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This pilot trial is testing whether a lower-toxicity chemotherapy combination can be a feasible option for adults aged 70 and older with HER2-negative breast cancer. The study aims to see how well older patients tolerate the treatment and whether they can complete the planned course. It compares different chemotherapy drugs (paclitaxel, cyclophosphamide, and carboplatin) to find a gentler yet effective approach.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of chemotherapy drugs (paclitaxel, cyclophosphamide, and carboplatin) given at lower toxicity levels
- What this could lead to
- If successful, this could lead to more tolerable chemotherapy regimens for older adults with breast cancer, improving their quality of life during treatment.
- What could go wrong
- This is a small pilot study, so results may not apply broadly. The lower-dose chemo might be less effective at preventing cancer recurrence, and side effects are still possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 41 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2019
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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70 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants must have histologically or cytologically confirmed breast cancer that is human epidermal growth factor receptor 2 negative (HER2-negative) per the most recent 2018 ASCO CAP guidelines94 * Estrogen Receptor and Progesterone immunohistochemistry (IHC) status must be known; any status is eligible, but this will define in which cohort a patient will enroll: * Additional eligibility for cohort 1: Triple negative disease- defined as IHC staining of \<10% for ER and PR per local pathology review * Additional eligibility for cohort 2: Hormone receptor-positive disease defined as IHC for ER or PR \>/= 10% per local pathology review * Men and women are eligible * Age 70 and older at the time of protocol registration * Non-metastatic, invasive breast cancer (scans are not required to document non-metastatic disease- any staging work-up is up to the treating provider's discretion) * Recommended to have either neoadjuvant chemotherapy or adjuvant chemotherapy per their treating provider. * Any surgery, nodal assessment, radiation, hormonal therapy is left up to the treating provider but should not occur concurrently with study therapy. If any additional chemotherapy is planned by a treating provider, this must occur AFTER all study-related chemotherapy is completed. * Any patient receiving pre-operative hormonal therapy and who is then recommended for adjuvant chemotherapy is eligible, though hormonal therapy should be held during study treatment administration * All study-related chemotherapy must be given prior to surgery if neoadjuvant therapy is planned or adjuvantly if postoperative chemotherapy is planned. For example, giving 6 doses pre-operatively and 6 doses postoperatively is not allowed on study. * There are no restrictions on life expectancy, ECOG Performance Status, or baseline blood values or organ function; Appropriateness of chemotherapy treatment is left up to the treating provider but providers should be ok with the full starting doses of each agent. * Participants must be willing to fill out surveys over time or designate a proxy to answer on their behalf. * Ability to understand and the willingness to sign a written informed consent document. * Patients who do not speak or read English are eligible as long as adequate interpreter services are available or the surveys are available in the preferred language (i.e. PRO surveys are available in many languages) Exclusion Criteria: * Participants who have already received chemotherapy for the current cancer. Prior diagnoses of breast cancers are allowed, provided that the treating provider feels that the current cancer represents a new primary breast cancer and not recurrent disease. * Participants who are receiving any other investigational or anti-cancer agents. Any additional radiation, hormonal therapy or chemotherapy planned should be administered once the study treatments have completed. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide, carboplatin, and paclitaxel. * Prior chemotherapy receipt is allowed in the setting of treatment of other/prior cancers, but no prior carboplatin (cohort 1), cyclophosphamide (cohort 2), or paclitaxel (both cohorts) receipt in the last 2 years is allowed (given toxicity and possible efficacy concerns
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope National Medical Center
Duarte, California, 91010, United States
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Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
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Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) at Milford Regional Medical Center
Milford, Massachusetts, 01757, United States
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Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital
South Weymouth, Massachusetts, 02190, United States
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Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103, United States
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