Breast CancerPhase 2NCT00209092
Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer
A Phase 2 study testing Docetaxel and Capecitabine in people with Breast Cancer, run by Emory University at 19 sites in United States.
Trial summary
The purpose of this study is 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 Cancer
- What is being tested?
- Docetaxel and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 19 sitesUnited States
- Study dates
- Aug 2006to Oct 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 central nervous system (CNS) metastases.
- Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory Crawford Long Hospital
Atlanta, Georgia, 30308
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
Augusta Oncology Associates, PC 1348 Walton Way, Ste. 4300
Augusta, Georgia, 30901
Augusta Oncology Associates, PC 3696 Wheeler Road
Augusta, Georgia, 30909
WellStar Health System-Georgia Cancer Specialists
Austell, Georgia, 30106
WellStar Health System-Northwest Georgia Oncology Center, PC
Austell, Georgia, 30106
WellStar Health System-Northwest Georgia Oncology Center, PC
Carrollton, Georgia, 30117
John B. Amos Cancer Center
Columbus, Georgia, 31904
Suburban Hematology-Oncology Associates, PC
Duluth, Georgia, 30096
South Atlanta Hematology-Oncology Group
East Point, Georgia, 30344
Suburban Hematology-Oncology Associates, PC
Lawrenceville, Georgia, 30045
Central Georgia Cancer Care, PC
Macon, Georgia, 31201
WellStar Health System-Georgia Cancer Specialists
Marietta, Georgia, 30060
WellStar Health System-Northwest Georgia Oncology Center, PC
Marietta, Georgia, 30060
South Atlanta Hematology-Oncology Group
Riverdale, Georgia, 30274
Suburban Hematology-Oncology Associates, PC
Snellville, Georgia, 30078
South Atlanta Hematology-Oncology Group
Stockbridge, Georgia, 30281
Central Georgia Cancer Care, PC
Warner Robins, Georgia, 31093
About this study
Official title: Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant, Dose-Dense Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer
The purpose of this study is 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.
- Conditions
- Breast Cancer
- Being tested
- Docetaxel, Capecitabine
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Sequential Therapy: Docetaxel will be given at 100 mg/m^2 Intravenously (IV)Day 1 every 3 weeks for 4 cycles.
Concurrent Therapy: Docetaxel will be given at 50 mg/m^2 IV Day 1.
CapecitabineDrug
Sequential Therapy: administration of capecitabine 1000 mg/m^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) Concurrent Therapy: capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Sequential Therapy | Active comparator | Docetaxel will be given at 100mg/m^2 intravenous Day 1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks). Receives: Drug: Docetaxel; Drug: Capecitabine |
| Concurrent Therapy | Active comparator | Docetaxel will be given at 50mg/m^2 Intravenous Day1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks). Receives: Drug: Docetaxel; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.
Pathologic complete response (pCR): Absence of invasive breast cancer in the breast.
Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignant disease)+partial response(PR-reduction by at least 30%)
Stable disease (SD): No decrease or <25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions.
Progressive disease (PD): A 20% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site.
Measured: 1 year
Secondary outcomes (1)
Long Term Follow up Data on Recurrence and Survival
Number of Patients remained alive and relapse free
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 posted21 Sep 2005 (estimated)
- Study startAug 2006
- Primary completionJul 2009
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Center for Oncology Research & Education, Sanofi
- Responsible party
- Principal investigator, Amelia Zelnak, Emory University
- Investigators
- Amelia Zelnak, MD, Principal investigator, Emory University Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209092
- Sponsor's protocol ID
- 1114-2003
- Status last verified
- Mar 2015
- First submitted
- 14 Sep 2005
- Last updated
- 27 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Zelnak AB, Styblo TM, Rizzo M, Gabram SG, Wood WC, Harichand-Herdt S, Kim S, Liu Y, O'Regan RM; Georgia Center for Oncology Research and Education. Final results from phase II trial of neoadjuvant docetaxel and capecitabine given sequentially or concurrently for HER2-negative breast cancers. Clin Breast Cancer. 2013 Jun;13(3):173-9. doi: 10.1016/j.clbc.2012.12.004. Epub 2013 Jan 16.
PubMed 23332349Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
PubMed 34037241
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. 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, Dose-Dense Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT00209092
- Acronym / sponsor ID
- 1114-2003
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Georgia Center for Oncology Research & Education, Sanofi
- Study start
- Aug 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 25 Jun 2012
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential Therapy | Active comparator | Drug: Docetaxel, Drug: CapecitabineDocetaxel will be given at 100mg/m^2 intravenous Day 1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks). |
| Concurrent Therapy | Active comparator | Drug: Docetaxel, Drug: CapecitabineDocetaxel will be given at 50mg/m^2 Intravenous Day1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks). |
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 central nervous system (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 |
|---|---|---|
| DocetaxelSequential Therapy: Docetaxel will be given at 100 mg/m^2 Intravenously (IV)Day 1 every 3 weeks for 4 cycles. Concurrent Therapy: Docetaxel will be given at 50 mg/m^2 IV Day 1. | Drug | Concurrent Therapy, Sequential Therapy |
| CapecitabineSequential Therapy: administration of capecitabine 1000 mg/m^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) Concurrent Therapy: capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks). | Drug | Concurrent Therapy, Sequential Therapy |
Primary outcome
Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.
Time frame: 1 year
Pathologic complete response (pCR): Absence of invasive breast cancer in the breast. Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignant disease)+partial response(PR-reduction by at least 30%) Stable disease (SD): No decrease or <25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions. Progressive disease (PD): A 20% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site.
1 secondary outcome
Long Term Follow up Data on Recurrence and Survival
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23332349Zelnak AB, Styblo TM, Rizzo M, Gabram SG, Wood WC, Harichand-Herdt S, Kim S, Liu Y, O'Regan RM; Georgia Center for Oncology Research and Education. Final results from phase II trial of neoadjuvant docetaxel and capecitabine given sequentially or concurrently for HER2-negative breast cancers. Clin Breast Cancer. 2013 Jun;13(3):173-9. doi: 10.1016/j.clbc.2012.12.004. Epub 2013 Jan 16.
- Derived from this study: PubMed 34037241Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
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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.
Amelia Zelnak, MD principal investigator
Emory University Winship Cancer Institute
19 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 and Capecitabine in people with Breast Cancer, run by Emory University at 19 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: finished, as of the sponsor's last update on 27 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 19 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?
Yes. Results are posted in the registry (first posted 25 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00209092, which also lists 2 linked publications.
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 27 Mar 2015.