Breast CancerPhase 2/3NCT00397761
Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer
A Phase 2/3 study testing capecitabine, paclitaxel albumin-stabilized nanoparticle formulation and neoadjuvant therapy in people with Breast Cancer, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and paclitaxel (albumin-stablized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- capecitabine, paclitaxel albumin-stabilized nanoparticle formulation and neoadjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to not given
- Phase
- Phase 2/3
- 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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed infiltrating carcinoma of the breast or inflammatory breast cancer
- Stage II-IIIB disease (T1-4, N1-2, M0)
- Previously untreated disease
- Previously unresected disease
- High-risk disease that is not resectable by lumpectomy alone
- Any HER2/neu status (positive, negative, or unknown) allowed
- Hormone receptor status:
- Any estrogen/progesterone status (positive, negative, or unknown) allowed
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- ECOG performance status 0-2
- Life expectancy > 3 months
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 100,000/mm³
- Hemoglobin > 9.0 g/dL
- Creatinine < 1.5 mg/dL
- Bilirubin < 1.5 times upper limit of normal (ULN)
- ALT and AST < 2.5 times ULN (5 times ULN if due to Gilbert's disease)
- Alkaline phosphatase < 2.5 times ULN (5 times ULN if due to Gilbert's disease)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Cancer Institute at Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as capecitabine and paclitaxel (albumin-stablized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II/III trial is studying how well giving capecitabine together with paclitaxel (albumin-stabilized nanoparticle formulation) works in treating women undergoing surgery for stage II or stage III breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the rate of pathological complete response (i.e., tumor completely gone) in women with previously untreated, unresected, stage II-IIIB breast cancer treated with neoadjuvant therapy comprising capecitabine and paclitaxel (albumin-stabilized nanoparticle formulation) (Abraxane^®).
Secondary
- Evaluate the safety of this regimen in these patients.
- Determine overall clinical response rate in patients treated with this regimen.
OUTLINE: Patients receive up to 4 courses of capecitabine and paclitaxel (nanoparticle albumin-stabilized formulation) (Abraxane^®) in the absence of disease progression. Patients then undergo definitive surgical resection of the tumor off study.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- capecitabine, paclitaxel albumin-stabilized nanoparticle formulation, neoadjuvant therapy
- Keywords
- inflammatory breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
- Medical subject headings
- Breast Neoplasms, Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
paclitaxel albumin-stabilized nanoparticle formulationDrug
neoadjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate
Secondary outcomes (2)
Safety
Overall clinical response rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startJul 2006
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 2/3
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Anita Aggarwal, DO, PhD, Study chair, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397761
- Sponsor's protocol ID
- CDR0000513169
- Other IDs
- WHC-MRI-GU-2006-097
- Status last verified
- Feb 2021
- First submitted
- 8 Nov 2006
- Last updated
- 17 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT00397761
- Acronym / sponsor ID
- CDR0000513169
- Conditions
- Breast Cancer
- Keywords
- inflammatory breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Jul 2006
- First posted
- 9 Nov 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.
RATIONALE: Drugs used in chemotherapy, such as capecitabine and paclitaxel (albumin-stablized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II/III trial is studying how well giving capecitabine together with paclitaxel (albumin-stabilized nanoparticle formulation) works in treating women undergoing surgery for stage II or stage III breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the rate of pathological complete response (i.e., tumor completely gone) in women with previously untreated, unresected, stage II-IIIB breast cancer treated with neoadjuvant therapy comprising capecitabine and paclitaxel (albumin-stabilized nanoparticle formulation) (Abraxane^®).
Secondary
- Evaluate the safety of this regimen in these patients.
- Determine overall clinical response rate in patients treated with this regimen.
OUTLINE: Patients receive up to 4 courses of capecitabine and paclitaxel (nanoparticle albumin-stabilized formulation) (Abraxane^®) in the absence of disease progression. Patients then undergo definitive surgical resection of the tumor off study.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| capecitabine | Drug | – |
| paclitaxel albumin-stabilized nanoparticle formulation | Drug | – |
| neoadjuvant therapy | Procedure or surgery | – |
Primary outcome
Pathological complete response rate
2 secondary outcomes
Safety
Overall clinical response rate
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
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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.
Anita Aggarwal, DO, PhD study chair
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing capecitabine, paclitaxel albumin-stabilized nanoparticle formulation and neoadjuvant therapy in people with Breast Cancer, run by Medstar Health Research Institute at 1 site 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?
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: withdrawn, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pathological complete response rate. 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 17 Feb 2021.