Breast NeoplasmsPhase 2NCT00415285
Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine for Early Stage Breast Cancer
A Phase 2 study testing Docetaxel, Capecitabine and Docetaxel/Capecitabine in people with Breast Neoplasms, run by Georgia Center for Oncology Research & Education at 3 sites in United States.
Trial summary
The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Docetaxel, Capecitabine and Docetaxel/Capecitabine
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2006to not given
- Phase
- Phase 2
- 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 or cytologically confirmed breast carcinoma.
- Early stage breast cancer (stage 1, 2, 3).
- No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.
- 18 years of age or older.
- Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Who cannot join
- Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
- Major surgery within 28 days of study entry.
- Evidence of CNS metastases.
- Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Trial locations and contacts
3 sites in 1 country.
Rita Johnson contact
United States3 sites, 3 recruiting
- Recruiting
Grady Memorial Hospital
Atlanta, Georgia, 30303
Rita Johnson, 404-778-7777
Ruth O'Regan
- Recruiting
Emory Crawford Long Hospital
Atlanta, Georgia, 30308
Rita Johnson, 404-778-7777
Ruth O'Regan
- Recruiting
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Rita Johnson, 404-778-7777
Ruth O'Regan
About this study
Official title: Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer
The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.
Read the detailed description
The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.
Induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo. Previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome. Additionally, we will correlate specific molecular markers in the breast tumors before and after chemotherapy, with response to treatment.
Expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively.
Approximately 100 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital and Grady Health System in Atlanta, Georgia.
- Conditions
- Breast Neoplasms
- Being tested
- Docetaxel, Capecitabine, Docetaxel/Capecitabine
- Keywords
- Breast, Cancer, Early-Stage, Chemotherapy
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
CapecitabineDrug
Docetaxel/CapecitabineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Georgia Center for Oncology Research & Education
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Ruth O'Regan, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415285
- Sponsor's protocol ID
- EU822-03
- Status last verified
- Feb 2007
- First submitted
- 20 Dec 2006
- Last updated
- 13 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT00415285
- Acronym / sponsor ID
- EU822-03
- Conditions
- Breast Neoplasms
- Keywords
- Breast, Cancer, Early-Stage, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Georgia Center for Oncology Research & EducationUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Dec 2006
- First posted
- 22 Dec 2006 (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 identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.
Detailed description
The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.
Induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo. Previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome. Additionally, we will correlate specific molecular markers in the breast tumors before and after chemotherapy, with response to treatment.
Expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively.
Approximately 100 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital and Grady Health System in Atlanta, Georgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (5 listed)
- Histologically or cytologically confirmed breast carcinoma.
- Early stage breast cancer (stage 1, 2, 3).
- No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.
- 18 years of age or older.
- Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Key exclusion criteria (4 listed)
- Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
- Major surgery within 28 days of study entry.
- Evidence of CNS metastases.
- Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
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 |
|---|---|---|
| Docetaxel | Drug | – |
| Capecitabine | Drug | – |
| Docetaxel/Capecitabine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2007.
- Winship Cancer InstituteLink provided by the sponsor.
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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.
Rita Johnson contact
Ruth O'Regan, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Capecitabine and Docetaxel/Capecitabine in people with Breast Neoplasms, run by Georgia Center for Oncology Research & Education at 3 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rita Johnson (404-778-7777), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 13 Feb 2007.