Breast CancerPhase 2NCT00201708
Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide in Axillary Node-Positive Breast Cancer
A Phase 2 study testing Docetaxel, Doxorubicin and Cyclophosphamide (AC) in people with Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study will determine if docetaxel will be administered before or after doxorubicin/cyclophosphamides in an adjuvant chemotherapy regimen to be evaluated in a subsequent phase III trial. 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?
- Docetaxel, Doxorubicin and Cyclophosphamide (AC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Feb 2014
- 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
Who may be able to join
- Must have histologically or cytologically confirmed breast cancer
- No metastatic disease
- Prior lumpectomy or mastectomy
- No prior chemotherapy or hormone treatments for breast cancer
- Must have normal organ and marrow function.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Who cannot join
- Peripheral neuropathy of grade II or higher.
- History or evidence upon physical exam of CNS (central nervous system Diseases)disease.
- History of unstable angina or myocardial infarction within the last six months.
- Pregnant or nursing women.
- Known allergies to polysorbate 80.
- HIV-positive patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Phase II Randomized Adjuvant Trial of Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide (AC) in Axillary Node-Positive Breast Cancer
This study will determine if docetaxel will be administered before or after doxorubicin/cyclophosphamides in an adjuvant chemotherapy regimen to be evaluated in a subsequent phase III trial.
Read the detailed description
Rationale: Studies suggest that chemotherapy agents docetaxel, doxorubicin, and cyclophosphamide have some efficacy against different types of breast cancer. However, the optimal sequence in which to administer these treatments remains unknown. The current study assesses two separate sequences of docetaxel, doxorubicin, and cyclophosphamide.
Purpose: This study will evaluate two different combination chemotherapy schedules for patients with axillary node-positive breast cancer. Combination one is docetaxel before doxorubicin and cyclophosphamide. Combination two is docetaxel after doxorubicin and cyclophosphamide. The combination with no dose reductions of docetaxel within 10 weeks will then be tested in a Phase III study. The toxicities of docetaxel will also be assessed in study participants.
Treatment: Patients in this study will receive one of two chemotherapy combination schedules. A computer will randomly assign patients into their treatment group. Group one will receive docetaxel before doxorubicin and cyclophosphamide. Group two will receive docetaxel after doxorubicin and cyclophosphamide.
Patients in group one will receive docetaxel every two weeks for a total of eight weeks. These patients will then be given combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks. Patients in group two will receive combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks. These patients will then be given docetaxel every two weeks for a total of eight weeks.
Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.
- Conditions
- Breast Cancer
- Being tested
- Docetaxel, Doxorubicin, Cyclophosphamide (AC)
- Keywords
- Adjuvant Trial, Dose-Dense, Axillary Node-Positive
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
Arm A:75 mg/m2 every 2 weeks)for 4 cycles. Arm B:75 mg/m2 every 2 weeks for 4 cycles.
DoxorubicinDrug
Also called Adriamycin, hydroxydaunorubicin
60 mg/m2 intravenously as push over 2-5 minutes, every 14 days for 4 cycles. Arms: Arm A (Docetaxel before doxorubicin/cyclophosphamide) , Arm B (Docetaxel after doxorubicin/cyclophosphamide)
Cyclophosphamide (AC)Drug
Also called Cytoxan, CPM, CTX, CYT
600 mg/m2 over 30 to 60 minutes every 14 days (2 weeks) for 4 cycles. Arms: Arm A (Docetaxel before doxorubicin/cyclophosphamide), Arm B (Docetaxel after doxorubicin/cyclophosphamide)
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Docetaxel before doxorubicin/cyclophosphamide) | Active comparator | Docetaxel 75 mg/m2 every 2 weeks for 4 cycles followed by "A" (doxorubicin) 60 mg/m2 \& "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles. Receives: Drug: Docetaxel; Drug: Doxorubicin; Drug: Cyclophosphamide (AC) |
| Arm B (Docetaxel after doxorubicin/cyclophosphamide) | Active comparator | "A" (doxorubicin) 60 mg/m2 \& "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles followed by Docetaxel 75 mg/m2 every 2 weeks for 4 cycles. Receives: Drug: Docetaxel; Drug: Doxorubicin; Drug: Cyclophosphamide (AC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Select one of two adjuvant chemotherapy regimens for evaluation in subsequent phase III trial.
Docetaxel before doxorubicin/cyclophosphamide(AC)or Docetaxel after AC. The regimen selection will be based on the proportion of patients receiving four cycles of Docetaxel with no dose reductions within 10 weeks.
Measured: up to 8 weeks
Secondary outcomes (1)
Determine the toxicities of Docetaxel administered before or after doxorubicin/cyclophosphamide(AC).
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionDec 2006
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Shapiro, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201708
- Sponsor's protocol ID
- OSU-0450
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2005
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Puhalla S, Mrozek E, Young D, Ottman S, McVey A, Kendra K, Merriman NJ, Knapp M, Patel T, Thompson ME, Maher JF, Moore TD, Shapiro CL. Randomized phase II adjuvant trial of dose-dense docetaxel before or after doxorubicin plus cyclophosphamide in axillary node-positive breast cancer. J Clin Oncol. 2008 Apr 1;26(10):1691-7. doi: 10.1200/JCO.2007.14.3941. Epub 2008 Mar 3.
PubMed 18316792
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Adjuvant Trial of Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide (AC) in Axillary Node-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00201708
- Acronym / sponsor ID
- OSU-0450
- Conditions
- Breast Cancer
- Keywords
- Adjuvant Trial, Dose-Dense, Axillary Node-Positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 Sep 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.
This study will determine if docetaxel will be administered before or after doxorubicin/cyclophosphamides in an adjuvant chemotherapy regimen to be evaluated in a subsequent phase III trial.
Detailed description
Rationale: Studies suggest that chemotherapy agents docetaxel, doxorubicin, and cyclophosphamide have some efficacy against different types of breast cancer. However, the optimal sequence in which to administer these treatments remains unknown. The current study assesses two separate sequences of docetaxel, doxorubicin, and cyclophosphamide.
Purpose: This study will evaluate two different combination chemotherapy schedules for patients with axillary node-positive breast cancer. Combination one is docetaxel before doxorubicin and cyclophosphamide. Combination two is docetaxel after doxorubicin and cyclophosphamide. The combination with no dose reductions of docetaxel within 10 weeks will then be tested in a Phase III study. The toxicities of docetaxel will also be assessed in study participants.
Treatment: Patients in this study will receive one of two chemotherapy combination schedules. A computer will randomly assign patients into their treatment group. Group one will receive docetaxel before doxorubicin and cyclophosphamide. Group two will receive docetaxel after doxorubicin and cyclophosphamide.
Patients in group one will receive docetaxel every two weeks for a total of eight weeks. These patients will then be given combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks. Patients in group two will receive combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks. These patients will then be given docetaxel every two weeks for a total of eight weeks.
Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (Docetaxel before doxorubicin/cyclophosphamide) | Active comparator | Drug: Docetaxel, Drug: Doxorubicin, Drug: Cyclophosphamide (AC)Docetaxel 75 mg/m2 every 2 weeks for 4 cycles followed by "A" (doxorubicin) 60 mg/m2 \& "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles. |
| Arm B (Docetaxel after doxorubicin/cyclophosphamide) | Active comparator | Drug: Docetaxel, Drug: Doxorubicin, Drug: Cyclophosphamide (AC)"A" (doxorubicin) 60 mg/m2 \& "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles followed by Docetaxel 75 mg/m2 every 2 weeks for 4 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must have histologically or cytologically confirmed breast cancer
- No metastatic disease
- Prior lumpectomy or mastectomy
- No prior chemotherapy or hormone treatments for breast cancer
- Must have normal organ and marrow function.
Key exclusion criteria (6 listed)
- Peripheral neuropathy of grade II or higher.
- History or evidence upon physical exam of CNS (central nervous system Diseases)disease.
- History of unstable angina or myocardial infarction within the last six months.
- Pregnant or nursing women.
- Known allergies to polysorbate 80.
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 |
|---|---|---|
| DocetaxelAlso: TaxotereArm A:75 mg/m2 every 2 weeks)for 4 cycles. Arm B:75 mg/m2 every 2 weeks for 4 cycles. | Drug | Arm A (Docetaxel before doxorubicin/cyclophosphamide), Arm B (Docetaxel after doxorubicin/cyclophosphamide) |
| DoxorubicinAlso: Adriamycin, hydroxydaunorubicin60 mg/m2 intravenously as push over 2-5 minutes, every 14 days for 4 cycles. Arms: Arm A (Docetaxel before doxorubicin/cyclophosphamide) , Arm B (Docetaxel after doxorubicin/cyclophosphamide) | Drug | Arm A (Docetaxel before doxorubicin/cyclophosphamide), Arm B (Docetaxel after doxorubicin/cyclophosphamide) |
| Cyclophosphamide (AC)Also: Cytoxan, CPM, CTX, CYT600 mg/m2 over 30 to 60 minutes every 14 days (2 weeks) for 4 cycles. Arms: Arm A (Docetaxel before doxorubicin/cyclophosphamide), Arm B (Docetaxel after doxorubicin/cyclophosphamide) | Drug | Arm A (Docetaxel before doxorubicin/cyclophosphamide), Arm B (Docetaxel after doxorubicin/cyclophosphamide) |
Primary outcome
Select one of two adjuvant chemotherapy regimens for evaluation in subsequent phase III trial.
Time frame: up to 8 weeks
Docetaxel before doxorubicin/cyclophosphamide(AC)or Docetaxel after AC. The regimen selection will be based on the proportion of patients receiving four cycles of Docetaxel with no dose reductions within 10 weeks.
1 secondary outcome
Determine the toxicities of Docetaxel administered before or after doxorubicin/cyclophosphamide(AC).
Time frame: up to 5 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 2 Sep 2016.
- Background: PubMed 18316792Puhalla S, Mrozek E, Young D, Ottman S, McVey A, Kendra K, Merriman NJ, Knapp M, Patel T, Thompson ME, Maher JF, Moore TD, Shapiro CL. Randomized phase II adjuvant trial of dose-dense docetaxel before or after doxorubicin plus cyclophosphamide in axillary node-positive breast cancer. J Clin Oncol. 2008 Apr 1;26(10):1691-7. doi: 10.1200/JCO.2007.14.3941. Epub 2008 Mar 3.
- JameslineLink 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.
Charles Shapiro, MD principal investigator
Ohio State University
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 Docetaxel, Doxorubicin and Cyclophosphamide (AC) in people with Breast Cancer, run by Ohio State University Comprehensive 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 6 inclusion and 6 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 2 Sep 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.
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.
What does the primary outcome measure?
Select one of two adjuvant chemotherapy regimens for evaluation in subsequent phase III trial. (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00201708, which also lists 1 linked publication.
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 2 Sep 2016.