Breast CancerPhase 2NCT00072319
Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer
A Phase 2 study testing filgrastim, cyclophosphamide and epirubicin hydrochloride in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. 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?
- filgrastim, cyclophosphamide and epirubicin hydrochloride
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Nov 2006
- Phase
- Phase 2
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
- Stage I, II, or III
- Inflammatory breast cancer allowed
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
- Not specified
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin normal
- SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) AND alkaline phosphatase no greater than ULN OR
- SGOT/SGPT no greater than ULN AND alkaline phosphatase no greater than 4 times ULN
Renal
- Not specified
Cardiovascular
- LVEF at least lower limit of normal by MUGA or echocardiogram
- No unstable angina
- No congestive heart failure
- No arrhythmia requiring medical therapy
- No myocardial infarction within the past year
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergy/hypersensitivity to any of the study drugs or other drugs formulated with Cremophor EL
- No psychiatric illness that would preclude understanding of the nature of the study or study compliance
- No active unresolved infection
- No peripheral neuropathy greater than grade 1
- No other nonmammary malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- No concurrent medical condition that would preclude study participation in the judgment of the investigator
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 12 months since prior immunotherapy for prior breast cancer
- No prior or concurrent biologic therapy or immunotherapy for this breast cancer
Chemotherapy
- More than 12 months since prior chemotherapy for prior breast cancer
- No prior anthracycline (i.e., doxorubicin or epirubicin) and taxane therapy
- No prior or other concurrent chemotherapy for this breast cancer
Endocrine therapy
- No concurrent hormonal therapy for chemoprevention
- Prior hormonal therapy for chemoprevention allowed
- No concurrent sex hormonal therapy (e.g., birth control pills or ovarian hormonal replacement therapy)
Radiotherapy
- No prior radiotherapy
- No other concurrent radiotherapy for this breast cancer
Surgery
- Not specified
Other
- No concurrent digitalis, beta-blockers, or calcium channel blockers for congestive heart failure
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Pilot Study of Epirubicin and Cyclophosphamide Followed by Paclitaxel at 10-11 Days Interval for Women With Early Breast Carcinoma
RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. Giving chemotherapy drugs after surgery may kill any remaining tumor cells.
PURPOSE: Pilot trial to study the effectiveness of neoadjuvant or adjuvant epirubicin, cyclophosphamide, and paclitaxel in treating women who have stage I, stage II, or stage III breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the feasibility and safety of neoadjuvant or adjuvant epirubicin, cyclophosphamide, and paclitaxel, in terms of the absence of any grade 3 or higher toxicity (aside from alopecia), in women with high-risk stage I-III breast cancer.
OUTLINE: This is a pilot study.
- Neoadjuvant or adjuvant EC therapy: Patients receive epirubicin IV over 3-5 minutes and cyclophosphamide IV (EC) on day 1 and filgrastim (G-CSF) subcutaneously on days 2-9 or 10. Treatment repeats every 10-11 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- Neoadjuvant or adjuvant paclitaxel therapy: After the completion of EC therapy, patients receive paclitaxel IV over 3 hours on day 1. Patients also receive G-CSF as in EC therapy. Treatment repeats every 10-11 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients who have not had prior surgery undergo definitive surgery after the completion of chemotherapy. Patients also may receive adjuvant radiotherapy and/or hormonal therapy at the discretion of the treating physician.
Patients are followed every 4 months for 3 years and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 11-38 patients will be accrued for this study within 1 year.
- Conditions
- Breast Cancer
- Being tested
- filgrastim, cyclophosphamide, epirubicin hydrochloride, paclitaxel, adjuvant therapy
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, inflammatory 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.
filgrastimBiological
cyclophosphamideDrug
epirubicin hydrochlorideDrug
paclitaxelDrug
adjuvant therapyProcedure or surgery
neoadjuvant therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2003 (estimated)
- Study startAug 2003
- Primary completionNov 2006
- Study completionNov 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.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Pharmacia, Amgen
- Responsible party
- Sponsor
- Investigators
- Monica N. Fornier, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072319
- Sponsor's protocol ID
- 03-092
- Other IDs
- P30CA008748, MSKCC-03092
- Status last verified
- Mar 2013
- First submitted
- 4 Nov 2003
- Last updated
- 4 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Epirubicin and Cyclophosphamide Followed by Paclitaxel at 10-11 Days Interval for Women With Early Breast Carcinoma
- ClinicalTrials.gov ID
- NCT00072319
- Acronym / sponsor ID
- 03-092
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, inflammatory breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Pharmacia, Amgen
- Study start
- Aug 2003
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 6 Nov 2003 (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 epirubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. Giving chemotherapy drugs after surgery may kill any remaining tumor cells.
PURPOSE: Pilot trial to study the effectiveness of neoadjuvant or adjuvant epirubicin, cyclophosphamide, and paclitaxel in treating women who have stage I, stage II, or stage III breast cancer.
Detailed description
OBJECTIVES:
- Determine the feasibility and safety of neoadjuvant or adjuvant epirubicin, cyclophosphamide, and paclitaxel, in terms of the absence of any grade 3 or higher toxicity (aside from alopecia), in women with high-risk stage I-III breast cancer.
OUTLINE: This is a pilot study.
- Neoadjuvant or adjuvant EC therapy: Patients receive epirubicin IV over 3-5 minutes and cyclophosphamide IV (EC) on day 1 and filgrastim (G-CSF) subcutaneously on days 2-9 or 10. Treatment repeats every 10-11 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- Neoadjuvant or adjuvant paclitaxel therapy: After the completion of EC therapy, patients receive paclitaxel IV over 3 hours on day 1. Patients also receive G-CSF as in EC therapy. Treatment repeats every 10-11 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients who have not had prior surgery undergo definitive surgery after the completion of chemotherapy. Patients also may receive adjuvant radiotherapy and/or hormonal therapy at the discretion of the treating physician.
Patients are followed every 4 months for 3 years and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 11-38 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| filgrastim | Biological | – |
| cyclophosphamide | Drug | – |
| epirubicin hydrochloride | Drug | – |
| paclitaxel | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 4 Mar 2013.
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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.
Monica N. Fornier, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim, cyclophosphamide and epirubicin hydrochloride in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center 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: finished, as of the sponsor's last update on 4 Mar 2013. 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 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?
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.
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 4 Mar 2013.