Breast CancerNCT00146588
Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer
A study testing Cyclophosphamide, Epirubicin and Capecitabine in people with Breast Cancer and Stage I Breast Cancer, run by Craig A. Bunnell, MD, MPH at 2 sites in United States.
Trial summary
The purpose of this study is to find out what effects (good and bad) a combination of cytoxan, epirubicin, and capecitabine have on women with Stage II/II/IIIA breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer
- What is being tested?
- Cyclophosphamide, Epirubicin and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2002to Dec 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed Stage I-III breast cancer. If Stage I, should be deemed of sufficiently high risk of developing recurrent disease to warrant participation.
- 18 years of age or older
- ANC > 1,000/mm3
- Platelet count > 100,000/mm3
- Hemoglobin > 10
- Creatinine < 2.0
Show all 11Show fewer
- SGOT < 2 x ULN
- Bilirubin < 1.5mg/dl
- Able to swallow and retain oral medication
- LVEF greater than or equal to 50%
- ECOG performance status of 0 or 1
Who cannot join
- Pregnant or lactating
- Prior malignancy within 5 years (excluding squamous or basal cell skin cancers)
- Prior chemotherapy within 5 years
- Prior anthracycline therapy
- Serious comorbid physical or psychological condition
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Center
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Study of Cytoxan, Epirubicin, and Capecitabine in Women With Stage I/II/IIIA Breast Cancer
The purpose of this study is to find out what effects (good and bad) a combination of cytoxan, epirubicin, and capecitabine have on women with Stage II/II/IIIA breast cancer.
Read the detailed description
- 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.
- Being tested
- Cyclophosphamide, Epirubicin, Capecitabine
- Keywords
- Breast cancer, cytoxan, epirubicin, capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called Cytoxan
Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.
EpirubicinDrug
Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.
CapecitabineDrug
Given orally on days 4-17 of each 21-day treatment cycle for 12-18 weeks depending upon response.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of administering cytoxan, epirubicin, and capecitabine to women with Stage I/II/IIIA breast cancer.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startApr 2002
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig A. Bunnell, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Pharmacia
- Responsible party
- Sponsor-investigator, Craig A. Bunnell, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Craig Bunnell, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146588
- Sponsor's protocol ID
- 02-036
- Status last verified
- Oct 2014
- First submitted
- 6 Sep 2005
- Last updated
- 24 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Cytoxan, Epirubicin, and Capecitabine in Women With Stage I/II/IIIA Breast Cancer
- ClinicalTrials.gov ID
- NCT00146588
- Acronym / sponsor ID
- 02-036
- Keywords
- Breast cancer, cytoxan, epirubicin, capecitabine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Craig A. Bunnell, MD, MPHUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Pharmacia
- Study start
- Apr 2002
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out what effects (good and bad) a combination of cytoxan, epirubicin, and capecitabine have on women with Stage II/II/IIIA breast cancer.
Detailed description
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed Stage I-III breast cancer. If Stage I, should be deemed of sufficiently high risk of developing recurrent disease to warrant participation.
- 18 years of age or older
- ANC > 1,000/mm3
- Platelet count > 100,000/mm3
- Hemoglobin > 10
Key exclusion criteria (5 listed)
- Pregnant or lactating
- Prior malignancy within 5 years (excluding squamous or basal cell skin cancers)
- Prior chemotherapy within 5 years
- Prior anthracycline therapy
- Serious comorbid physical or psychological condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideAlso: CytoxanIntravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response. | Drug | – |
| EpirubicinIntravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response. | Drug | – |
| CapecitabineGiven orally on days 4-17 of each 21-day treatment cycle for 12-18 weeks depending upon response. | Drug | – |
Primary outcome
To determine the feasibility of administering cytoxan, epirubicin, and capecitabine to women with Stage I/II/IIIA breast cancer.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Bunnell, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclophosphamide, Epirubicin and Capecitabine in people with Breast Cancer and Stage I Breast Cancer, run by Craig A. Bunnell, MD, MPH at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the feasibility of administering cytoxan, epirubicin, and capecitabine to women with Stage I/II/IIIA breast cancer. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.