Breast CancerPhase 3NCT00190489
A Trial of Doxorubicin/Cyclophosphamide (AC), Docetaxel (D), and Alternating AC and D for Metastatic Breast Cancer
A Phase 3 study testing AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles, Docetaxel 60mg/m2 every 21 days for 6 cycles and AC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles in people with Breast Cancer and Neoplasm Metastasis, run by Japan Clinical Oncology Group at 1 site in Japan.
Trial summary
To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison with standard AC for metastatic breast cancer Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Neoplasm Metastasis
- What is being tested?
- AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles, Docetaxel 60mg/m2 every 21 days for 6 cycles and AC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles
- How many people
- 450 participants
- Where
- 1 siteJapan
- Study dates
- Jan 1999to May 2006
- Phase
- Phase 3
- 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 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hormonal therapy-resistant MBC
- ER (-), failure of hormonal therapy for MBC, or relapse within 6 months after adjuvant hormonal therapy
- No anthracyclines for MBC and no prior taxanes
- At least 6 months from the completion of adjuvant chemotherapy
- Measurable or evaluable lesions
- Age: 20 to 75 years
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- PS: 0-3
- WBC >= 4,000 /mm3 or ANC >=1,000 /mm3, Platelet >= 100,000 /mm3, SGOT/SGPT <= 1.5 x ULN, T-Bil <= 1.5 mg/dL, Cr <= 1.5 mg/dL
- normal ECG
- Written informed consent
Who cannot join
- pregnant
- malignant pleural effusion, ascites, or pericardial effusion that requires emergent treatment
- Active infection
- other cancer present within the last 5 years
- previous stem cell transplantation
- brain metastasis that requires emergent treatment
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- relapse within 6 months after completion anthracycline or during anthracycline
- more than 250mg/m2 of anthracyclines
- hypersensitivity of drug
- interstitial pneumonitis or pulmonary fibrosis
- positive HBs
- antipsychotic medication
- doctor's judgement
Trial locations and contacts
1 site in 1 country.
Japan1 site
National Cancer Center Hospital
Chuo-ku, Tsukiji, 5-1-1, Tokyo, 104-0045
About this study
Official title: Phase III Trial of Doxorubicin /Cyclophosphamide (AC), Docetaxel (D), and Alternating AC and D (AC-D) as Front-line Chemotherapy for Metastatic Breast Cancer: Japan Clinical Oncology Group Trial (JCOG9802)
To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison with standard AC for metastatic breast cancer
Read the detailed description
power to detect a 50% increase in median TTF at 0.025 one-sided alpha in AC vs. D and AC vs. AC-D.
Results: 441pts (146 in AC, 147 in D, 148 in AC-D) were randomized between 01/99 and 05/03. Major grade 3-4 toxicities were neutropenia (26/45/46% for AC/D/AC-D), febrile neutropenia (3/4/6%), nausea/vomiting (3/3/4%). There was no toxic death. One grade 4 diarrhea in AC-D and 1 secondary leukemia (APL) in D were reported. Response (CR/PR) rates were 30, 41, and 35% for AC, D, and AC-D respectively. Median TTF (AC, D, and AC-D) are 6.4, 6.4, and 6.7 months (p =.255 for AC vs. D, p =.275 for AC vs. AC-D), and median overall survival are 22.4, 25.7, and 25.0 months (p=.092 for AC vs. D, p=.076 for AC vs. AC-D). The same difference was shown by the adjusted Cox model.
Conclusions: No benefit was demonstrated in D and AC-D over AC in TTF, however, D and AC-D tended to be superior to AC in response rate and overall survival. Survival benefit of front-line docetaxel should be re-evaluated by further long follow-up.
- Conditions
- Breast Cancer, Neoplasm Metastasis
- Being tested
- AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles, Docetaxel 60mg/m2 every 21 days for 6 cycles, AC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles
- Keywords
- metastatic breast cancer, drug therapy, doxorubicin, docetaxel
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cyclesDrug
Docetaxel 60mg/m2 every 21 days for 6 cyclesDrug
AC and Docetaxel 60mg/m2 alternately q21 days for 6 cyclesDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
time to treatment failure
Secondary outcomes (4)
overall survival
progression-free survival
response rate
adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJan 1999
- Primary completionMay 2006
- Study completionMay 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants
Sponsor and investigators
- Lead sponsor
- Japan Clinical Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Investigators
- Shigemitsu Takashima, MD, PhD, Study chair, National Shikoku Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190489
- Sponsor's protocol ID
- JCOG9802
- Other IDs
- C000000179
- Status last verified
- Aug 2016
- First submitted
- 12 Sep 2005
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
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 III Trial of Doxorubicin /Cyclophosphamide (AC), Docetaxel (D), and Alternating AC and D (AC-D) as Front-line Chemotherapy for Metastatic Breast Cancer: Japan Clinical Oncology Group Trial (JCOG9802)
- ClinicalTrials.gov ID
- NCT00190489
- Acronym / sponsor ID
- JCOG9802
- Conditions
- Breast Cancer, Neoplasm Metastasis
- Keywords
- metastatic breast cancer, drug therapy, doxorubicin, docetaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- Japan Clinical Oncology GroupUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Jan 1999
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 19 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.
To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison with standard AC for metastatic breast cancer
Detailed description
power to detect a 50% increase in median TTF at 0.025 one-sided alpha in AC vs. D and AC vs. AC-D.
Results: 441pts (146 in AC, 147 in D, 148 in AC-D) were randomized between 01/99 and 05/03. Major grade 3-4 toxicities were neutropenia (26/45/46% for AC/D/AC-D), febrile neutropenia (3/4/6%), nausea/vomiting (3/3/4%). There was no toxic death. One grade 4 diarrhea in AC-D and 1 secondary leukemia (APL) in D were reported. Response (CR/PR) rates were 30, 41, and 35% for AC, D, and AC-D respectively. Median TTF (AC, D, and AC-D) are 6.4, 6.4, and 6.7 months (p =.255 for AC vs. D, p =.275 for AC vs. AC-D), and median overall survival are 22.4, 25.7, and 25.0 months (p=.092 for AC vs. D, p=.076 for AC vs. AC-D). The same difference was shown by the adjusted Cox model.
Conclusions: No benefit was demonstrated in D and AC-D over AC in TTF, however, D and AC-D tended to be superior to AC in response rate and overall survival. Survival benefit of front-line docetaxel should be re-evaluated by further long follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Hormonal therapy-resistant MBC
- ER (-), failure of hormonal therapy for MBC, or relapse within 6 months after adjuvant hormonal therapy
- No anthracyclines for MBC and no prior taxanes
- At least 6 months from the completion of adjuvant chemotherapy
- Measurable or evaluable lesions
Key exclusion criteria (13 listed)
- pregnant
- malignant pleural effusion, ascites, or pericardial effusion that requires emergent treatment
- Active infection
- other cancer present within the last 5 years
- previous stem cell transplantation
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 |
|---|---|---|
| AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles | Drug | – |
| Docetaxel 60mg/m2 every 21 days for 6 cycles | Drug | – |
| AC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles | Drug | – |
Primary outcome
time to treatment failure
4 secondary outcomes
overall survival
progression-free survival
response rate
adverse events
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.
- Related InfoLink 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.
Shigemitsu Takashima, MD, PhD study chair
National Shikoku 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 3 study testing AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles, Docetaxel 60mg/m2 every 21 days for 6 cycles and AC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles in people with Breast Cancer and Neoplasm Metastasis, run by Japan Clinical Oncology Group at 1 site in Japan.
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 10 inclusion and 13 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 Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
time to treatment failure. 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 2 Sep 2016.