Breast CancerNCT00131963
A Pharmacogenomics Study for Breast Cancer Patients Undergoing Adjuvant Chemotherapy With Doxorubicin (A)/Cyclophosphamide ©) and/or Weekly Paclitaxel
An observational study of Breast Cancer, run by Duke University at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, 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) may kill more tumor cells. 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?
- cyclophosphamide, doxorubicin and paclitaxel
- Type of treatment
- Injection or infusion
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Oct 2014
- Phase
- Observational
- 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
Study population: Subjects will be recruited from the breast cancer oncology clinics.
Who may be able to join
None listed.
Who cannot join
- Other anticancer cytotoxic or endocrine therapy, immunotherapy, or biologic response modifiers,Study Drugs or other concomitant medications known to cause myelosuppression especially neutropenia and neuropathy
- Eastern Cooperative Oncology Group Performance Status(ECOG) functional status > 2.
- Serious co-morbidities including poorly controlled diabetes mellitus, ischaemic heart disease,uncontrolled hypertension or active infection.
- Pregnancy
- Use of growth factor during cycle 1 of chemotherapy (AC) under pharmacokinetic evaluation
- Grade >/=2 peripheral neuropathy symptoms based on National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) Scale. Exception: a chronic neurologic disorder will be reviewed on a case by case basis by the study PI.
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- Prior treatment with weekly paclitaxelDISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:
- Node negative disease AND meets 1 of the following stage criteria:
- Primary tumor > T1c
- Primary tumor > T1b AND poor prognostic features, defined as the following:
- High-grade disease
- Human Epidermal Growth Factor Receptor 2 (HER2)/neu-positive disease by fluorescence in situ hybridization
- Estrogen receptor-negative disease
- Stage II disease (T2, N0)
- Node positive nonmetastatic disease
- Locally advanced disease AND receiving neoadjuvant chemotherapy comprising doxorubicin and cyclophosphamide OR paclitaxel
- Enrolled in clinical trial CALGB-40101
- No evidence of systemic metastasis
- Hormone receptor status:
- Not specified
Trial locations and contacts
1 site in 1 country.
About this study
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, 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) may kill more tumor cells. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well doxorubicin, cyclophosphamide, and/or paclitaxel work in treating women with nonmetastatic breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the pharmacogenomics of adjuvant chemotherapy comprising doxorubicin and cyclophosphamide and/or paclitaxel in women with nonmetastatic invasive breast cancer.
- Determine treatment-induced myelosuppression (e.g., neutropenia) in patients treated with adjuvant doxorubicin and cyclophosphamide who have polymorphisms in drug activation and metabolism genes.
- Correlate the incidence of peripheral neuropathy with pharmacogenomic analysis in patients treated with paclitaxel.
Secondary
- Determine response (i.e., relapse in the adjuvant setting) during a 10-year follow-up period in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients receive treatment on The Cancer and Leukemia Group B study(CALGB) CALGB-40101 OR are assigned to receive 1 of 2 treatment regimens on this study.
- Regimen 1: Patients receive doxorubicin IV over 10 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.
- Regimen 2: Patients receive doxorubicin and cyclophosphamide as in regimen 1. Patients then receive paclitaxel IV over 1 hour once weekly for 12 weeks.
After completion of study treatment, patients are followed at 3, 6, and 12 months and then annually for up to 10 years.
PROJECTED ACCRUAL: A total of 500 patients (300 treated with doxorubicin and cyclophosphamide and 200 treated with paclitaxel) will be accrued for this study within 3-4 years.
- Conditions
- Breast Cancer
- Being tested
- cyclophosphamide, doxorubicin, paclitaxel
- Keywords
- stage One A (IA) breast cancer, stage Two (II) breast cancer, stage Three A (IIIA) breast cancer, stage Three B(IIIB) breast cancer, stage Three C(IIIC) breast cancer, stage One B (IB) 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.
cyclophosphamideDrug
Also called Cytoxan
Given IV
doxorubicinDrug
Also called adriamycin
Given IV
paclitaxelDrug
Also called taxol
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Regimen 1 | Patients receive doxorubicin IV over 10 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. Receives: Drug: cyclophosphamide; Drug: doxorubicin | |
| Regimen 2 | Patients receive doxorubicin and cyclophosphamide as in regimen 1. Patients then receive paclitaxel IV over 1 hour once weekly for 12 weeks. Receives: Drug: cyclophosphamide; Drug: doxorubicin; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-induced myelosuppression (e.g., neutropenia)
Measured: 12 months
Incidence of peripheral neuropathy
Measured: 12 month
Secondary outcomes (1)
Response (relapse in adjuvant setting) for 10 years after completion of study treatment
Measured: Ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startOct 2003
- Primary completionOct 2014
- Study completionOct 2014
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.
- More trials run by Duke 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Paul K. Marcom, MD, Principal investigator, Duke Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131963
- Sponsor's protocol ID
- Pro00014267
- Other IDs
- DUMC-4522-04-1-R1, CDR0000438673
- Status last verified
- Nov 2015
- First submitted
- 16 Aug 2005
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacogenomics Study for Breast Cancer Patients Undergoing Adjuvant Chemotherapy With Doxorubicin (A)/Cyclophosphamide ©) and/or Weekly Paclitaxel
- ClinicalTrials.gov ID
- NCT00131963
- Acronym / sponsor ID
- Pro00014267
- Conditions
- Breast Cancer
- Keywords
- stage One A (IA) breast cancer, stage Two (II) breast cancer, stage Three A (IIIA) breast cancer, stage Three B(IIIB) breast cancer, stage Three C(IIIC) breast cancer, stage One B (IB) breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2003
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Aug 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.
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, 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) may kill more tumor cells. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well doxorubicin, cyclophosphamide, and/or paclitaxel work in treating women with nonmetastatic breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the pharmacogenomics of adjuvant chemotherapy comprising doxorubicin and cyclophosphamide and/or paclitaxel in women with nonmetastatic invasive breast cancer.
- Determine treatment-induced myelosuppression (e.g., neutropenia) in patients treated with adjuvant doxorubicin and cyclophosphamide who have polymorphisms in drug activation and metabolism genes.
- Correlate the incidence of peripheral neuropathy with pharmacogenomic analysis in patients treated with paclitaxel.
Secondary
- Determine response (i.e., relapse in the adjuvant setting) during a 10-year follow-up period in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients receive treatment on The Cancer and Leukemia Group B study(CALGB) CALGB-40101 OR are assigned to receive 1 of 2 treatment regimens on this study.
- Regimen 1: Patients receive doxorubicin IV over 10 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.
- Regimen 2: Patients receive doxorubicin and cyclophosphamide as in regimen 1. Patients then receive paclitaxel IV over 1 hour once weekly for 12 weeks.
After completion of study treatment, patients are followed at 3, 6, and 12 months and then annually for up to 10 years.
PROJECTED ACCRUAL: A total of 500 patients (300 treated with doxorubicin and cyclophosphamide and 200 treated with paclitaxel) will be accrued for this study within 3-4 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen 1 | – | Drug: cyclophosphamide, Drug: doxorubicinPatients receive doxorubicin IV over 10 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. |
| Regimen 2 | – | Drug: cyclophosphamide, Drug: doxorubicin, Drug: paclitaxelPatients receive doxorubicin and cyclophosphamide as in regimen 1. Patients then receive paclitaxel IV over 1 hour once weekly for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the breast cancer oncology clinics.
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- Other anticancer cytotoxic or endocrine therapy, immunotherapy, or biologic response modifiers,Study Drugs or other concomitant medications known to cause myelosuppression especially neutropenia and neuropathy
- Eastern Cooperative Oncology Group Performance Status(ECOG) functional status > 2.
- Serious co-morbidities including poorly controlled diabetes mellitus, ischaemic heart disease,uncontrolled hypertension or active infection.
- Pregnancy
- Use of growth factor during cycle 1 of chemotherapy (AC) under pharmacokinetic evaluation
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: CytoxanGiven IV | Drug | Regimen 1, Regimen 2 |
| doxorubicinAlso: adriamycinGiven IV | Drug | Regimen 1, Regimen 2 |
| paclitaxelAlso: taxolGiven IV | Drug | Regimen 2 |
Primary outcome
Treatment-induced myelosuppression (e.g., neutropenia)
Time frame: 12 months
Incidence of peripheral neuropathy
Time frame: 12 month
1 secondary outcome
Response (relapse in adjuvant setting) for 10 years after completion of study treatment
Time frame: Ten 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 25 Jul 2016.
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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.
Paul K. Marcom, MD principal investigator
Duke Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Duke University 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?
The sponsor lists 0 inclusion and 21 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 25 Jul 2016. 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.
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?
Treatment-induced myelosuppression (e.g., neutropenia) (time frame: 12 months). The study lists 2 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 25 Jul 2016.