TerminatedPhase 2

Capecitabine in Women With Operable Breast Cancer

Stopped: Slow accrual

United States80 participantsStarted 2004-09

Plain-language summary

The purpose of this study is to find out what effects (good and bad) taking capecitabine for 12 weeks before surgery will have on women with breast cancer.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histological confirmation of primary invasive breast cancer * Stage I-III operable breast cancer. * Primary tumor must be greater than or equal to 2cm by radiographic imaging or palpitation * Women greater than 18 years of age * ECOG performance status 0-1 * WBC \> 4000/mm3 * Platelet count \> 100,000/mm3 * SGOT \< 2x ULN * Calculated creatinine clearance \> 50ml/min Exclusion Criteria: * Evidence of metastatic (stage IV) cancer on physical exam or any diagnostic study. * Pregnant or breast-feeding women * Inflammatory breast cancer * HER2 positive disease * History of hypersensitivity to a 5-FU or known dihydropyrimidine dehydrogenase (DPD) deficiency * Uncontrolled intercurrent illness * Prior history of breast cancer are ineligible except: diagnosed at least 2 years ago; present cancer is not in previously irradiated breast; no prior chemotherapy in the past 5 years; no prior high-dose chemotherapy with stem cell or bone marrow transplant. * Excisional biopsy performed prior to enrollment * Uncontrolled coagulopathy * Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer.

Timeframe: 3 years

Trial details

NCT IDNCT00148720

SponsorDana-Farber Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-09

View on ClinicalTrials.gov More Invasive Breast Carcinoma trials