Breast CancerPhase 3NCT00352378
Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer
A Phase 3 study testing Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine in people with Breast Cancer, run by National Cancer Center, Korea.
Trial summary
This is an open labeled phase III randomized trial. The patients with clinical stage II and III will undergo mammotome biopsy of breast tumor for histologic diagnosis, immunohistochemical studies for estrogen receptor(ER), progesterone receptor(PR), HER-2/neu and others. 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?
- Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Jan 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must have histologically confirmed and newly diagnosed breast cancer: stage II and III breast cancer.
- PET results will determine node positivity.
- No prior hormonal , chemotherapy or radiotherapy is allowed.
- No breast operation other than biopsy to make diagnosis is allowed.
- Age:18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
- Adequate hematopoietic function:
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- Absolute granulocyte count >=1500/mm3,
- platelet >=100,000/mm3, Hemoglobin >=10 g/mm3
- Adequate renal function: Serum creatinine <=1.5 mg/dl
- Adequate hepatic function:
- total bilirubin: <=1.5 mg/dl
- AST/ALT: <=three times normal
- Alkaline phosphatase: <=three times normal
- Adequate cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment
Who cannot join
- Patients who received hormonal , chemotherapy or radiotherapy for breast cancer
- Patients who underwent surgery for breast cancer
- Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
About this study
Official title: A Phase III Randomized Study of Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer
This is an open labeled phase III randomized trial. The patients with clinical stage II and III will undergo mammotome biopsy of breast tumor for histologic diagnosis, immunohistochemical studies for estrogen receptor(ER), progesterone receptor(PR), HER-2/neu and others. PET results will determine the positivity of lymph node metastasis.
Read the detailed description
- Patients will be randomized to receive regimen A (AC) and regimen B(TX), preoperatively,as follows: Regimen A (AC): Intravenous infusion of Adriamycin 60mg/m2 , over 30 min, onD1 and Intravenous infusion of cyclophosphamide 600 mg/m2 over 30 min on D1. Regimen B(TX): Intravenous infusion of Taxotere 75 mg/m2 over 1 hr, on D1, and Xeloda 1000mg/m2.p.o. BID x 14days on D1-D14 The cycle repeats every 3 weeks for 4 times. Premedication for regimen A includes antiemetics, for regimen B, dexamethasone as routinely given.
Patients who do not respond to the initial two cycles of preoperative chemotherapy will undergo operation.
The response rate will be determined by the number of patients with complete and partial responses according to RECIST guidelines. Pathologic complete response is defined as no pathologic evidence of residual disease. Safety will be evaluated by the frequency, severity, and relationship of adverse events graded by NCI Common Toxicity Criteria(CTC) that occur during the treatment and follow-up periods. Time to disease progression will be calculated from the date of study entry to the first objective documentation of progressive disease. Response duration will be measured from the date a patient first fulfills the CR or PR criteria to the first date of objective documentation of disease progression. Survival time will be calculated from the date of study entry to the date of death
- Conditions
- Breast Cancer
- Being tested
- Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine
- Keywords
- Primary
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthracycline, Cyclophosphamide, Docetaxel, CapecitabineDrug
Also called Taxotere, Xeloda, Cytoxan, doxorubicin
Patients will be randomized to receive regimen A (AC) and regimen B(TX),preoperatively as follows:
Regimen A (AC): Intravenous infusion of Adriamycin 60mg/m2 , over 30 min, onD1 and Intravenous infusion of cyclophosphamide 600 mg/m2 over 30 min on D1. Regimen B(TX): Intravenous infusion of Taxotere 75 mg/m2 over 1 hr, on D1, and Xeloda 1000mg/m2.p.o. BID x 14days on D1-D14
| Study group | Role | What they receive |
|---|---|---|
| Adriamycin plus Cyclophosphamide | Experimental | Intravenous infusion of Adriamycin 60mg/m2 , over 30 min, onD1 and Intravenous infusion of cyclophosphamide 600 mg/m2 over 30 min on D1. Receives: Drug: Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine |
| Taxotere plus Xeloda | Experimental | Intravenous infusion of Taxotere 75 mg/m2 over 1 hr, on D1, and Xeloda 1000mg/m2.p.o. BID x 14days on D1-D14 Receives: Drug: Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete remission
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startJun 2002
- Primary completionOct 2005
- Study completionJan 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Investigators
- Jungsil Ro, MD,PhD, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352378
- Sponsor's protocol ID
- NCCCTS-02-034
- Status last verified
- Sep 2007
- First submitted
- 13 Jul 2006
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Study of Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer
- ClinicalTrials.gov ID
- NCT00352378
- Acronym / sponsor ID
- NCCCTS-02-034
- Conditions
- Breast Cancer
- Keywords
- Primary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jun 2002
- Primary completion
- Oct 2005 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 14 Jul 2006 (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 is an open labeled phase III randomized trial. The patients with clinical stage II and III will undergo mammotome biopsy of breast tumor for histologic diagnosis, immunohistochemical studies for estrogen receptor(ER), progesterone receptor(PR), HER-2/neu and others. PET results will determine the positivity of lymph node metastasis.
Detailed description
- Patients will be randomized to receive regimen A (AC) and regimen B(TX), preoperatively,as follows: Regimen A (AC): Intravenous infusion of Adriamycin 60mg/m2 , over 30 min, onD1 and Intravenous infusion of cyclophosphamide 600 mg/m2 over 30 min on D1. Regimen B(TX): Intravenous infusion of Taxotere 75 mg/m2 over 1 hr, on D1, and Xeloda 1000mg/m2.p.o. BID x 14days on D1-D14 The cycle repeats every 3 weeks for 4 times. Premedication for regimen A includes antiemetics, for regimen B, dexamethasone as routinely given.
Patients who do not respond to the initial two cycles of preoperative chemotherapy will undergo operation.
The response rate will be determined by the number of patients with complete and partial responses according to RECIST guidelines. Pathologic complete response is defined as no pathologic evidence of residual disease. Safety will be evaluated by the frequency, severity, and relationship of adverse events graded by NCI Common Toxicity Criteria(CTC) that occur during the treatment and follow-up periods. Time to disease progression will be calculated from the date of study entry to the first objective documentation of progressive disease. Response duration will be measured from the date a patient first fulfills the CR or PR criteria to the first date of objective documentation of disease progression. Survival time will be calculated from the date of study entry to the date of death
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adriamycin plus Cyclophosphamide | Experimental | Drug: Anthracycline, Cyclophosphamide, Docetaxel, CapecitabineIntravenous infusion of Adriamycin 60mg/m2 , over 30 min, onD1 and Intravenous infusion of cyclophosphamide 600 mg/m2 over 30 min on D1. |
| Taxotere plus Xeloda | Experimental | Drug: Anthracycline, Cyclophosphamide, Docetaxel, CapecitabineIntravenous infusion of Taxotere 75 mg/m2 over 1 hr, on D1, and Xeloda 1000mg/m2.p.o. BID x 14days on D1-D14 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- All patients must have histologically confirmed and newly diagnosed breast cancer: stage II and III breast cancer.
- PET results will determine node positivity.
- No prior hormonal , chemotherapy or radiotherapy is allowed.
- No breast operation other than biopsy to make diagnosis is allowed.
- Age:18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
Key exclusion criteria (3 listed)
- Patients who received hormonal , chemotherapy or radiotherapy for breast cancer
- Patients who underwent surgery for breast cancer
- Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
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 |
|---|---|---|
| Anthracycline, Cyclophosphamide, Docetaxel, CapecitabineAlso: Taxotere, Xeloda, Cytoxan, doxorubicinPatients will be randomized to receive regimen A (AC) and regimen B(TX),preoperatively as follows: Regimen A (AC): Intravenous infusion of Adriamycin 60mg/m2 , over 30 min, onD1 and Intravenous infusion of cyclophosphamide 600 mg/m2 over 30 min on D1. Regimen B(TX): Intravenous infusion of Taxotere 75 mg/m2 over 1 hr, on D1, and Xeloda 1000mg/m2.p.o. BID x 14days on D1-D14 | Drug | Adriamycin plus Cyclophosphamide, Taxotere plus Xeloda |
Primary outcome
pathologic complete remission
Time frame: 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 27 Jun 2011.
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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.
Jungsil Ro, MD,PhD principal investigator
National Cancer Center, Korea
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anthracycline, Cyclophosphamide, Docetaxel, Capecitabine in people with Breast Cancer, run by National Cancer Center, Korea.
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 14 inclusion and 3 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 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
pathologic complete remission (time frame: 5 years). 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 27 Jun 2011.