Breast CancerPhase 1NCT00107094
Study of Adriamycin Plus Cyclophosphamide Followed by Abraxane as Adjuvant Therapy for Patients With Breast Cancer
A Phase 1 study testing Abraxane in people with Breast Cancer, run by Celgene Corporation at 1 site in United States.
Trial summary
In this trial, the safety of combination treatment of Adriamycin plus cyclophosphamide followed by Abraxane as adjuvant therapy will be evaluated in patients with limited stage breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Abraxane
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to not given
- Phase
- Phase 1
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient will be eligible for inclusion in this study only if all of the following criteria are met:
- Estrogen Receptor (ER) and Progesterone Receptor (PR) status have been determined
- Operable, histologically confirmed adenocarcinoma of the breast
- Must meet 1 of the following criteria:
- T1-3, N1-2, M0, regardless of ER or PR status;
- T >2 cm, N0, M0, regardless of ER or PR status;
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- T >1 cm, N0, M0 and both ER and PR negative;
- T1-2 and 1 sentinel node with micrometastasis <2 mm with or without axillary dissection, M0;
- T1-2 and >1 sentinel node micrometastasis or 1 node with a macrometastasis >2 mm and/or T3 must have axillary dissection, M0.
- Negative surgical margins to lumpectomy or mastectomy specimen (no ink on invasive cancer and no ink on DCIS [ductal carcinoma in situ]).
- ECOG performance status 0-1
- Adequate wound healing, as determined by the treating physician
- It has not been longer than 84 days since the date of definitive surgery (e.g.,mastectomy or, in the case of a breast-sparing procedure, axillary dissection).
- Previous invasive cancers if treated >5 years prior to entering this study, except basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, the latter are not required to have occurred more than 5 years prior to study entry.
- Prior invasive breast cancer if diagnosed >5 years prior to entering study. Patients must have finished adjuvant hormonal therapy prior to registration. Patients with prior DCIS are eligible. Patients with DCIS who were treated with tamoxifen must have finished tamoxifen prior to registration.
- Laboratory values must be as follows:
- White blood cell count: ≥3,000/mm3;
- Absolute neutrophil count: ≥1,500/mm3;
- Platelets: ≥100,000/mm3;
- Hemoglobin: ≥8 g/dL;
- Bilirubin: ≤ the institution's ULN (upper limit of normal);
- Creatinine: ≤1.5 mg/dL;
- Calculated creatinine clearance >30 mL/min;
- AST and ALT and alkaline phosphatase may be up to 2.5 × institutional ULN.
- All staging studies including physical exam, chest x-ray, and bone scan must show no evidence of metastatic disease, including suspicious lymphadenopathy or skin nodules on physical exam. A chest x-ray and bone scan are mandatory; however, all other staging studies are at the treating physician's discretion. Any other staging test (e.g., CT scans, MRI studies, ultrasound of abdomen, PET scans) must be negative for metastatic disease. An abdominal CT scan or PET scan is mandatory for patients with liver function tests elevated above the ULN to rule out metastatic disease.
- Patient has a negative serum pregnancy test within 10 days prior to registration (patients of childbearing potential).
- If fertile, patient has agreed to use an acceptable method of birth control to avoid pregnancy [Note: oral contraceptives are not allowed] for the duration of the study.
- Patient has signed a Patient Informed Consent Form
Who cannot join
- A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- Any evidence of disease following surgical resection of the primary tumor including: positive surgical margins, staging work-up, or physical examination suspicious for malignant disease.
- Stage IIIb breast cancer (T4 disease, i.e., patients with fixed tumors, peau d'orange skin changes, skin ulcerations, or inflammatory changes).
- Stage IV breast cancer.
- Prior anthracycline, anthracenedione (mitoxantrone), or taxane therapy.
- Neoadjuvant therapy for this breast cancer.
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- Peripheral neuropathy >Grade 1.
- Serious medical illness, other than that treated by this study, which would limit survival to <2 years, or psychiatric condition that would prevent informed consent.
- Uncontrolled or severe cardiovascular disease including recent (<6 months) myocardial infarction, or congestive heart failure.
- Active uncontrolled bacterial, viral (including clinically defined AIDS), or fungal infection.
- Patients with active hepatitis with abnormal LFTs (liver function tests) or patients who are known to be HIV positive
- Uncontrolled disease such as uncontrolled diabetes
- Obese patient to whom the Investigator is not comfortable administering full doses of study drugs as calculated by the BSA (body surface area).
- Patients receiving concurrent immunotherapy.
- A history of other malignancy within the last 5 years, which could affect the diagnosis or assessment of high-risk breast cancer.
- Patient has had an organ allograft.
- Patient is pregnant or breastfeeding.
- Patient is unable to comply with study requirements.
- Patient is receiving any investigational drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abraxis BioScience Inc.
Durham, North Carolina, 27703
About this study
Official title: An Open Label, Pilot Study of Dose-Dense Adriamycin Plus Cyclophosphamide (AC) Followed by ABI-007 as Adjuvant Therapy for Patients With Breast Cancer
In this trial, the safety of combination treatment of Adriamycin plus cyclophosphamide followed by Abraxane as adjuvant therapy will be evaluated in patients with limited stage breast cancer.
Read the detailed description
This is an open-label, pilot study to evaluate the safety of Adriamycin and cyclophosphamide (AC) administered every 2 weeks for 4 cycles followed by Abraxane administered every 2 weeks for 4 cycles as adjuvant therapy for patients with limited stage breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Abraxane
- Keywords
- Breast Cancer, Adriamycin, Cyclophosphamide, Abraxane
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbraxaneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/tolerability endpoints:
incidence of treatment-emergent/related adverse events and serious adverse events
laboratory abnormalities
nadir of myelosuppression
incidence of patients experiencing dose modifications, dose interruptions, and/or premature discontinuation of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2005 (estimated)
- Study startMar 2005
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Celgene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Hawkins, M.D., Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107094
- Sponsor's protocol ID
- CA030
- Status last verified
- Jul 2007
- First submitted
- 5 Apr 2005
- Last updated
- 20 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Pilot Study of Dose-Dense Adriamycin Plus Cyclophosphamide (AC) Followed by ABI-007 as Adjuvant Therapy for Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT00107094
- Acronym / sponsor ID
- CA030
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Adriamycin, Cyclophosphamide, Abraxane
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Celgene CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- First posted
- 6 Apr 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.
In this trial, the safety of combination treatment of Adriamycin plus cyclophosphamide followed by Abraxane as adjuvant therapy will be evaluated in patients with limited stage breast cancer.
Detailed description
This is an open-label, pilot study to evaluate the safety of Adriamycin and cyclophosphamide (AC) administered every 2 weeks for 4 cycles followed by Abraxane administered every 2 weeks for 4 cycles as adjuvant therapy for patients with limited stage breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- A patient will be eligible for inclusion in this study only if all of the following criteria are met:
- Estrogen Receptor (ER) and Progesterone Receptor (PR) status have been determined
- Operable, histologically confirmed adenocarcinoma of the breast
- Must meet 1 of the following criteria:
- Negative surgical margins to lumpectomy or mastectomy specimen (no ink on invasive cancer and no ink on DCIS [ductal carcinoma in situ]).
Key exclusion criteria (19 listed)
- A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- Any evidence of disease following surgical resection of the primary tumor including: positive surgical margins, staging work-up, or physical examination suspicious for malignant disease.
- Stage IIIb breast cancer (T4 disease, i.e., patients with fixed tumors, peau d'orange skin changes, skin ulcerations, or inflammatory changes).
- Stage IV breast cancer.
- Prior anthracycline, anthracenedione (mitoxantrone), or taxane therapy.
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 |
|---|---|---|
| Abraxane | Drug | – |
Primary outcome
Safety/tolerability endpoints:
incidence of treatment-emergent/related adverse events and serious adverse events
laboratory abnormalities
nadir of myelosuppression
incidence of patients experiencing dose modifications, dose interruptions, and/or premature discontinuation of study drug
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 20 Jul 2007.
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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.
Michael Hawkins, M.D. study director
Celgene Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abraxane in people with Breast Cancer, run by Celgene Corporation 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 28 inclusion and 19 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 20 Jul 2007. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Safety/tolerability endpoints:. The study lists 5 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 20 Jul 2007.