Breast CancerPhase 2NCT00347438
Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer
A Phase 2 study testing Capecitabine in people with Breast Cancer, run by University of Chicago at 3 sites in 2 countries.
Trial summary
The purpose of this study is to assess the safety and effectiveness of capecitabine before surgery. The study will also help gain more information about the effects of the capecitabine on physical and emotional well-being and how well the participants on capecitabine follow the study drug plan. 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?
- Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2006to Mar 2013
- 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
- Patients with locally advanced, histologically confirmed adenocarcinoma of the female breast. Women with ulcerated breast lesions may be enrolled. Patients with asymptomatic metastases to the bone are eligible.
- Ability to provide written informed consent prior to study-specific screening procedures
- TNM Stage:T3-4, N0-3 M0; Patients with asymptomatic bone metastases may be enrolled. Patients with large T2 tumors whose surgeons believe their results with breast conserving surgery will be improved by neoadjuvant therapy may be enrolled.
- Age 18 years or older
- Negative serum or urine pregnancy test within 7 days prior to starting therapy (female patients of childbearing potential).
- Performance status 0-1
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- Required Initial Laboratory Data:
- Granulocytes >=1,200/µl
- Platelet count >=100,000/µl
- Calculated Creatinine Clearance > 30 mL/min
- Total bilirubin <= Upper Limit Normal
- Alkaline Phosphatase <=Upper Limit Normal
- SGPT, SGOT <=Upper Limit Normal
- Normal chest x-ray
Who cannot join
- HER2 positive breast cancer
- Pregnant or lactating woman
- Life expectancy < 3 months
- Serious, uncontrolled, concurrent infection(s)
- Any prior fluoropyrimidine therapy or other chemotherapy
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hyper-sensitivity to 5-fluorouracil or known DPD deficiency.
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- Patients who have received more than four weeks of tamoxifen therapy for this malignancy.
- Treatment for other carcinomas within the last five years, except cured non- melanoma skin and treated in-situ cervical cancer.
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
- Evidence of metastatic disease to sites other than the bone or with symptomatic bone lesions.
- Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- Known, existing uncontrolled coagulopathy or concurrent treatment with Coumadin and Phenytoin
- Any of the following laboratory values:
- Abnormal hematologic values (neutrophils < 1.0 x 109/L, platelet count < 100 x 109/L)
- Impaired renal function (estimated creatinine clearance <30ml/min as calculated with Cockcroft-Gault equation)
- Serum bilirubin > upper normal limit.
- SGOT, SGPT > upper normal limit
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: A Phase II Study to Evaluate the Efficacy, Safety, and Genomic Markers of Response of Capecitabine as NeoAdjuvant Therapy in Women With Newly Diagnosed Locally Advanced Breast Cancer
The purpose of this study is to assess the safety and effectiveness of capecitabine before surgery.
The study will also help gain more information about the effects of the capecitabine on physical and emotional well-being and how well the participants on capecitabine follow the study drug plan.
- Conditions
- Breast Cancer
- Being tested
- Capecitabine
- Keywords
- breast cancer, neoadjuvant, locally advanced
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
Capecitabine twice daily for 14 days followed by 7 days without taking drug (1 cycle). This schedule is followed for 8 cycles (about 24 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine | Experimental | Capecitabine will be given at 1000mg/m2 twice daily for 2 weeks x 8 cycles, with a one-week pause in-between cycles. Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Clinical Response Rate (OCR)
Overall clinical response rate (OCR) was defined as a proportion of patients with a best response of Complete Clinical Response (CCR) or Partial Clinical Response (PCR). CCR was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease. PCR was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.
Measured: After the first three cycles of therapy, an average of 9 weeks
Partial Clinical Response Rate (PR)
Partial Clinical Response (PR) was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.
Measured: After the first three cycles of therapy, an average of 9 weeks
Complete Clinical Response Rate (CCR)
Complete Clinical Response (CCR) was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease.
Measured: After the first three cycles of therapy, an average of 9 weeks
Complete Pathologic Response Rate (cPR)
Complete Pathologic Response rate (cPR) was defined as the absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery.
Measured: After the first three cycles of therapy, an average of 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startSep 2006
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: a result of slow accrual
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.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation, Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Olufunmilayo I Olopade, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347438
- Sponsor's protocol ID
- 14201B
- Status last verified
- Nov 2015
- First submitted
- 29 Jun 2006
- Last updated
- 14 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Efficacy, Safety, and Genomic Markers of Response of Capecitabine as NeoAdjuvant Therapy in Women With Newly Diagnosed Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00347438
- Acronym / sponsor ID
- 14201B
- Conditions
- Breast Cancer
- Keywords
- breast cancer, neoadjuvant, locally advanced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: a result of slow accrual
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation, Roche Pharma AG
- Study start
- Sep 2006
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Jul 2006 (estimated)
- Results
- Posted 14 Dec 2015
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 assess the safety and effectiveness of capecitabine before surgery.
The study will also help gain more information about the effects of the capecitabine on physical and emotional well-being and how well the participants on capecitabine follow the study drug plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine | Experimental | Drug: CapecitabineCapecitabine will be given at 1000mg/m2 twice daily for 2 weeks x 8 cycles, with a one-week pause in-between cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients with locally advanced, histologically confirmed adenocarcinoma of the female breast. Women with ulcerated breast lesions may be enrolled. Patients with asymptomatic metastases to the bone are eligible.
- Ability to provide written informed consent prior to study-specific screening procedures
- TNM Stage:T3-4, N0-3 M0; Patients with asymptomatic bone metastases may be enrolled. Patients with large T2 tumors whose surgeons believe their results with breast conserving surgery will be improved by neoadjuvant therapy may be enrolled.
- Age 18 years or older
- Negative serum or urine pregnancy test within 7 days prior to starting therapy (female patients of childbearing potential).
Key exclusion criteria (18 listed)
- HER2 positive breast cancer
- Pregnant or lactating woman
- Life expectancy < 3 months
- Serious, uncontrolled, concurrent infection(s)
- Any prior fluoropyrimidine therapy or other chemotherapy
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 |
|---|---|---|
| CapecitabineAlso: XelodaCapecitabine twice daily for 14 days followed by 7 days without taking drug (1 cycle). This schedule is followed for 8 cycles (about 24 weeks). | Drug | Capecitabine |
Primary outcome
Overall Clinical Response Rate (OCR)
Time frame: After the first three cycles of therapy, an average of 9 weeks
Overall clinical response rate (OCR) was defined as a proportion of patients with a best response of Complete Clinical Response (CCR) or Partial Clinical Response (PCR). CCR was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease. PCR was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.
Partial Clinical Response Rate (PR)
Time frame: After the first three cycles of therapy, an average of 9 weeks
Partial Clinical Response (PR) was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.
Complete Clinical Response Rate (CCR)
Time frame: After the first three cycles of therapy, an average of 9 weeks
Complete Clinical Response (CCR) was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease.
Complete Pathologic Response Rate (cPR)
Time frame: After the first three cycles of therapy, an average of 9 weeks
Complete Pathologic Response rate (cPR) was defined as the absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Olufunmilayo I Olopade, MD principal investigator
University of Chicago
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine in people with Breast Cancer, run by University of Chicago at 3 sites in 2 countries.
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 14 inclusion and 18 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: stopped early, as of the sponsor's last update on 14 Dec 2015. 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 Nigeria, 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 14 Dec 2015). 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?
Overall Clinical Response Rate (OCR) (time frame: After the first three cycles of therapy, an average of 9 weeks). The study lists 4 primary outcomes in all. 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 14 Dec 2015.