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Breast NeoplasmsPhase 2/3NCT00525642

Study of Suitable Schedule of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy of Beast Cancer

A Phase 2/3 study testing Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide in people with Breast Neoplasms and Adjuvant, run by Fudan University at 5 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Anthracycline based regimens followed by a taxane (CALGB-9344 trial and NSABP-B28) or reversed (MD Anderson Adjuvant Trial) has already accepted as adjuvant therapy for node positive breast cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Neoplasms, Adjuvant, Chemotherapy
What is being tested?
Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
603 participants
Where
5 sitesChina
Study dates
Jun 2003to Jun 2015
Phase
Phase 2/3
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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • pT1-3,pN1-3,M0, operable breast cancer
  • Karnofsky >=80
  • Pregnant test negative

Who cannot join

  • Prior Chemotherapy with anthracyclines and / or Taxanes, except for Neoadjuvant therapy
  • Prior breast radiation
  • Bilateral breast cancer
  • in-operable breast cancer
  • Other health condition which may be contraindications for chemotherapy
  • contraindications for Dexamethasone

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Beijing 307 Hospital

    Beijing, Beijing Municipality

  • No2 affiliated hospital of Sun Yat-sen medical Univesity

    Guangzhou, Guangdong

  • Cancer Hospital / Institute, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shanghai No.6 hospital

    Shanghai, Shanghai Municipality

  • Liaoning Province Cancer Hospital

    Shenyang, Liaoning

Other trials in China

About this study

Official title: A Chinese Multi-Center,Randomized Study of Combination or Sequential Use of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy for Node Positive Breast Cancer

Anthracycline based regimens followed by a taxane (CALGB-9344 trial and NSABP-B28) or reversed (MD Anderson Adjuvant Trial) has already accepted as adjuvant therapy for node positive breast cancer. Also in this group of patients, data from BCIRG-001 trial had shown that six cycles of adjuvant TAC (docetaxel, doxorubicin and cyclophosphamide) is superior to standard FAC (5-FU, doxorubicin and cyclophosphamide ) combination in terms of both disease free and overall survival, while associated with a higher rate of febrile neutropenia. Then question arose whether it is better to use docetaxel and anthracycline in combination or sequence.

Read the detailed description

In this national wide study, women with node positive operable breast cancer are eligible for inclusion.Patients were designed to randomize to six cycles of adjuvant TAC (Taxotere® 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2), and four cycles of T(100mg/m2), followed by 4 cycles of AC(doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2). Prophylaxis with G-CSF was allowed for two arms when febrile neutropenia occurred in the first cycle of the study treatment. The second endpoint of this study is disease free survival. The primary objective is to compare the disease free survival rate and safety profiles of the above mentioned two arms.

Being tested
Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
Keywords
Breast-adjuvant, Breast-chemotherapy, Combination chemotherapy regimens
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docetaxel, Doxorubicin or Epirubicin, CyclophosphamideDrug

    Also called Docetaxel=Taxotere®

    Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 six cycles

  • Docetaxel, Doxorubicin or Epirubicin, CyclophosphamideDrug

    Also called Docetaxel= Taxotere®

    Docetaxel 100mg/m2 four cycles; Doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2) four cycles

Study groups in NCT00525642
Study groupRoleWhat they receive
AExperimentalsix cycles of adjuvant TAC
Receives: Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
BExperimentalfour cycles of T followed by 4 cycles of AC
Receives: Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Free Survival

    Measured: 5 years and 10 years

  2. Grade III/IV Adverse Event,Severe Adverse Event

    Measured: during chemotherapy and 30 days after treatment

Secondary outcomes (3)

  1. Overall Survival

    Measured: 5 years and 10 years

  2. Distant disease free Survival

    Measured: 5 years and 10 years

  3. Time to treatment failure

    Measured: 5 years and 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2007 (estimated)
  2. Study startJun 2003
  3. Study completionJun 2015 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
603 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00525642
Sponsor's protocol ID
TAX-619
Status last verified
Aug 2007
First submitted
4 Sep 2007
Last updated
6 Sep 2007
Results posted
No
Data monitoring committee
Yes

Publications

  • Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.

    PubMed 15761078

  • Yang L, Li LD, Chen YD, Parkin DM. [Time trends, estimates and projects for breast cancer incidence and mortality in China]. Zhonghua Zhong Liu Za Zhi. 2006 Jun;28(6):438-40. Chinese.

    PubMed 17152490

  • Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C; Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005 Jun 2;352(22):2302-13. doi: 10.1056/NEJMoa043681.

    PubMed 15930421

  • Nabholtz JM, Falkson G, Campos D, et al. A phase III trial comparing doxorubicin (A) and docetaxel (T) (AT) to doxorubicin and cyclophosphamide (AC) as first line chemotherapy for MBC. Proc. Amer. Soc. Clin. Oncol. (1999) 18: 127a (Abstr 485).

  • I.B.Ambulkaar, et al.Neoadjuvant sequential chemotherapy with docetaxel followed by epirubicin and cyclophosphamide in locally advanced breast cancer. Proc. Amer. Soc. Clin. Oncol. 2003 (Abstr 226)

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide in people with Breast Neoplasms and Adjuvant, run by Fudan University at 5 sites in China.

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 3 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: status not confirmed, as of the sponsor's last update on 6 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. 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 combined 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.

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?

Results are not available in the source record.

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?

Disease Free Survival (time frame: 5 years and 10 years). The study lists 2 primary outcomes in all. 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 NCT00525642, which also lists 5 linked publications.

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 6 Sep 2007.

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