deltatrials
Completed NA INTERVENTIONAL NCT00146588

Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer

A Pilot Study of Cytoxan, Epirubicin, and Capecitabine in Women With Stage I/II/IIIA Breast Cancer

Sponsor: Beth Israel Deaconess Medical Center

Updated 7 times since 2017 Last updated: Mar 23, 2015 Started: Apr 30, 2002 Primary completion: Dec 31, 2004 Completion: Dec 31, 2004
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00146588, this NA trial focuses on Breast Cancer and Stage I Breast Cancer and remains completed. Sponsored by Beth Israel Deaconess Medical Center, it has been updated 7 times since 2002, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

* Each treatment cycle lasts 21 days and patients will participate in a least 4 cycles, but no more than 6 cycles of treatment. * Patients will receive cytoxan (cyclophosphamide) and epirubicin intravenously on day 1 of each treatment cycle. On days 4-17 of each cycle, patients will take capecitabine orally twice a day. * While on the study patients will be required to complete a diary of they capecitabine treatment. * Blood tests will be performed each week along with surveys at the beginning of the trial and certain follow-up visits to evaluate the patient's experience with the oral chemotherapy. * Patients will be on the treatment for 12-18 weeks depending upon whether or not the disease progresses or the patient develops inacceptable side effects.

* Each treatment cycle lasts 21 days and patients will participate in a least 4 cycles, but no more than 6 cycles of treatment. * Patients will receive cytoxan (cyclophosphamide) and epirubicin intravenously on day 1 of each treatment cycle. On days 4-17 of each cycle, patients will take capecitabine orally twice a day. * While on the study patients will be required to complete a diary of they capecitabine treatment. * Blood tests will be performed each week along with surveys at the beginning of the trial and certain follow-up visits to evaluate the patient's experience with the oral chemotherapy. * Patients will be on the treatment for 12-18 weeks depending upon whether or not the disease progresses or the patient develops inacceptable side effects.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed NA

  2. Sep 2024 — Present [monthly]

    Completed NA

  3. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  4. Jan 2021 — Jul 2024 [monthly]

    Completed NA

  5. Jun 2018 — Jan 2021 [monthly]

    Completed NA

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Completed NA

  2. Jan 2017 — Feb 2017 [monthly]

    Completed NA

    First recorded

Apr 2002

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Craig A. Bunnell, MD, MPH
  • Dana-Farber Cancer Institute
  • Massachusetts General Hospital
  • Pharmacia
Data source: Dana-Farber Cancer Institute

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations