Breast CancerNCT00617370
Dose-Dense Epirubicin and Cyclophosphamide (EC) Followed by Paclitaxel in Breast Cancer: Feasibility
A study testing epirubicin, cyclophosphamide, Paclitaxel, in people with Breast Cancer and Adenocarcinoma of the Breast, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to give a drug regimen that is hoped to be effective in preventing cancer from coming back. Since it is an aggressive breast cancer, there is a moderate to high chance that the cancer may come back. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Adenocarcinoma of the Breast
- What is being tested?
- epirubicin, cyclophosphamide, Paclitaxel,
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Jun 2008
- Phase
- Interventional
- 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
Who may be able to join
- Patients must have histologically confirmed adenocarcinoma of the breast confirmed at MSKCC or MSKCC satellites. Patients with breast cancer, regardless of tumor size or nodal status, are eligible for the study. Pathology will be assessed in the standard fashion (ie: HER-2/neu, estrogen receptor, and progesterone receptor status). Results of HER-2/neu, estrogen receptor, and progesterone receptor are not required for study entry.
- Patients must be ≥18 years of age.
- Patients must have an ECOG PS of 0 or 1.
- If patients are offered chemotherapy postoperatively, then they must be within 84 days from the final surgical procedure required to treat the primary tumor(s). If patients are offered chemotherapy preoperatively, then they can receive treatment at anytime per MD's discretion. Patients may have bilateral synchronous breast tumors.
- Patients may have received hormonal therapy for the purpose of chemoprevention but must be willing to discontinue prior to enrollment and while participating in this trial.
- If patients have peripheral neuropathy, it must be < than or equal grade 1.
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- Patients must be willing to discontinue sex hormonal therapy e.g., birth control pills, ovarian hormonal replacement therapy, etc., prior to enrollment. Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.
- Absolute neutrophil count (ANC) ≥1000/µL and platelet count ≥100,000/µL.
- Total Bilirubin must be within normal limits. Transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is < than or equal to ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < than or equal to ULN.
- Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause.
- LVEF (by multi-gated radionuclide angiography or MUGA scan or by echocardiography)at or above institutional lower limit of normal
- Patients must give written, informed consent indicating their understanding of and willingness to participate in the study.
Who cannot join
- Stage IV breast cancer
- Chemotherapy, radiation therapy, immunotherapy, or biotherapy for current breast cancer.
- Pregnant or lactating patients.
- Patients with a concurrently active second malignancy, other than adequately treated nonmelanoma skin cancers or in situ cervical cancer. Patients with other non-mammary malignancies must have been disease-free for at least five years.
- Patients with known allergy/hypersensitivity to doxorubicin, cyclophosphamide, paclitaxel (or other drugs formulated in Cremophor EL) or E. coli-derived proteins.
- Patients with unstable angina, congestive heart failure, current use of digitalis, betablockers, or calcium blockers for therapy of congestive heart failure, arrhythmia requiring medical therapy, or with a history of a myocardial infarction within 12 months.
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- Patients with a psychiatric illness that would prevent them from understanding the nature of the investigational therapy and complying with protocol requirements.
- Patients with concurrent medical conditions, which, in the judgment of the investigator, would make them inappropriate candidates for study enrollment.
- Patients with active, unresolved infections.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Pilot Study of Dose-Dense Epirubicin and Cyclophosphamide (EC) Followed by Paclitaxel in High-Risk Breast Cancer: Feasibility
The purpose of this study is to give a drug regimen that is hoped to be effective in preventing cancer from coming back. Since it is an aggressive breast cancer, there is a moderate to high chance that the cancer may come back. The standard treatment for this tumor type includes a chemotherapy regimen with drugs named epirubicin (E) and cyclophosphamide (C) in a vein every 2 weeks for 4 treatments, followed by a drug named paclitaxel, every 2 weeks in your vein for 4 treatments.
This study is an experimental study in which you will be given 6 cycles of EC followed by 6 cycles of paclitaxel. The purpose of getting 2 more cycles of EC and 2 more cycles of paclitaxel than what is normally given is to study a regimen that may be more effective than the current standard treatment in preventing the recurrence of this cancer. Specifically, in this study we are looking for side-effects and risks of these drugs as more cycles are given.
- Conditions
- Breast Cancer, Adenocarcinoma of the Breast
- Being tested
- epirubicin, cyclophosphamide, Paclitaxel,
- Keywords
- CYCLOPHOSPHAMIDE (CYTOXAN), EPIRUBICIN, PEGFILGRASTIM, TAXOL (PACLITAXEL)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epirubicin, cyclophosphamide, Paclitaxel,Drug
EC (epirubicin 100 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 6 treatments with pegfilgrastim SQ day # 2 (6 mg). Paclitaxel (175 mg/m2) q 14 days x 6 treatments with pegfilgrastim SQ day # 2 (6 mg).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The regimen consists of EC (epirubicin 100 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 6 with pegfilgrastim subcutaneously (SQ) on day # 2, followed by paclitaxel (175 mg/m2) q 14 days x 6 with pegfilgrastim SQ on day # 2. Receives: Drug: epirubicin, cyclophosphamide, Paclitaxel, |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility and safety of this dose-dense regimen.
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startNov 2004
- Primary completionJul 2005
- Study completionJun 2008
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chau Dang, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617370
- Sponsor's protocol ID
- 04-065
- Status last verified
- Dec 2015
- First submitted
- 4 Feb 2008
- Last updated
- 23 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Dose-Dense Epirubicin and Cyclophosphamide (EC) Followed by Paclitaxel in High-Risk Breast Cancer: Feasibility
- ClinicalTrials.gov ID
- NCT00617370
- Acronym / sponsor ID
- 04-065
- Conditions
- Breast Cancer, Adenocarcinoma of the Breast
- Keywords
- CYCLOPHOSPHAMIDE (CYTOXAN), EPIRUBICIN, PEGFILGRASTIM, TAXOL (PACLITAXEL)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Amgen, Pfizer
- Study start
- Nov 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 18 Feb 2008 (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.
The purpose of this study is to give a drug regimen that is hoped to be effective in preventing cancer from coming back. Since it is an aggressive breast cancer, there is a moderate to high chance that the cancer may come back. The standard treatment for this tumor type includes a chemotherapy regimen with drugs named epirubicin (E) and cyclophosphamide (C) in a vein every 2 weeks for 4 treatments, followed by a drug named paclitaxel, every 2 weeks in your vein for 4 treatments.
This study is an experimental study in which you will be given 6 cycles of EC followed by 6 cycles of paclitaxel. The purpose of getting 2 more cycles of EC and 2 more cycles of paclitaxel than what is normally given is to study a regimen that may be more effective than the current standard treatment in preventing the recurrence of this cancer. Specifically, in this study we are looking for side-effects and risks of these drugs as more cycles are given.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: epirubicin, cyclophosphamide, Paclitaxel,The regimen consists of EC (epirubicin 100 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 6 with pegfilgrastim subcutaneously (SQ) on day # 2, followed by paclitaxel (175 mg/m2) q 14 days x 6 with pegfilgrastim SQ on day # 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have histologically confirmed adenocarcinoma of the breast confirmed at MSKCC or MSKCC satellites. Patients with breast cancer, regardless of tumor size or nodal status, are eligible for the study. Pathology will be assessed in the standard fashion (ie: HER-2/neu, estrogen receptor, and progesterone receptor status). Results of HER-2/neu, estrogen receptor, and progesterone receptor are not required for study entry.
- Patients must be ≥18 years of age.
- Patients must have an ECOG PS of 0 or 1.
- If patients are offered chemotherapy postoperatively, then they must be within 84 days from the final surgical procedure required to treat the primary tumor(s). If patients are offered chemotherapy preoperatively, then they can receive treatment at anytime per MD's discretion. Patients may have bilateral synchronous breast tumors.
- Patients may have received hormonal therapy for the purpose of chemoprevention but must be willing to discontinue prior to enrollment and while participating in this trial.
Key exclusion criteria (9 listed)
- Stage IV breast cancer
- Chemotherapy, radiation therapy, immunotherapy, or biotherapy for current breast cancer.
- Pregnant or lactating patients.
- Patients with a concurrently active second malignancy, other than adequately treated nonmelanoma skin cancers or in situ cervical cancer. Patients with other non-mammary malignancies must have been disease-free for at least five years.
- Patients with known allergy/hypersensitivity to doxorubicin, cyclophosphamide, paclitaxel (or other drugs formulated in Cremophor EL) or E. coli-derived proteins.
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 |
|---|---|---|
| epirubicin, cyclophosphamide, Paclitaxel,EC (epirubicin 100 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 6 treatments with pegfilgrastim SQ day # 2 (6 mg). Paclitaxel (175 mg/m2) q 14 days x 6 treatments with pegfilgrastim SQ day # 2 (6 mg). | Drug | 1 |
Primary outcome
To evaluate the feasibility and safety of this dose-dense regimen.
Time frame: conclusion of the study
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 23 Dec 2015.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Chau Dang, 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 study testing epirubicin, cyclophosphamide, Paclitaxel, in people with Breast Cancer and Adenocarcinoma of the Breast, 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?
The sponsor lists 12 inclusion and 9 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 23 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 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?
To evaluate the feasibility and safety of this dose-dense regimen. (time frame: conclusion of the study). 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 23 Dec 2015.