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Efficacy Study of Adjuvant Chemotherapy for Chinese Primary Breast Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Chinese Anti-Cancer Association
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01314833
First received: March 9, 2011
Last updated: March 14, 2011
Last verified: July 2010
  Purpose

In recent years, the increasing number of breast cancer patients shows the fact breast cancer is one of the most common cancers in women in China. However, the mortality rate has seen a dramatic decline mainly due to early detection of breast cancer and the use of effective multimodel treatment. Recent studies suggest breast cancers are heterogeneous and recognized by biological subtypes, which lead to markedly different clinical outcome.

Adjuvant chemotherapy is widely used in the treatment for primary breast cancer patients. Different types of breast cancer cells are sensitive to different types of drugs.There is no data to support the information about the adjuvant chemotherapy regimens for different subtypes breast cancer patients, especially for Chinese women.

The investigators hypothesized to confirm the possibility of finding the adjuvant chemotherapy aimed to different subtypes of breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: Docetaxel Cyclophosphamide
Drug: Cyclophosphamide Fluorouracil Epirubicin Docetaxel
Drug: Epirubicin Cyclophosphamide Paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Prospective Open Multicentric Phase III Clinical Trial Compared TC, FEC100 Followed by Docetaxel and EC90 Followed by Paclitaxel as Adjuvant Chemotherapy for Chinese Primary Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Disease Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Percentage of Participants without Disease Recurrence and Distance Metastasis after 5 years


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Percentage of Survival Participants after 10 years

  • Recurrence Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Percentage of Participants without Disease Recurrence after 5 years

  • Adverse Events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Number of Participants with Adverse Events


Estimated Enrollment: 3200
Study Start Date: June 2010
Estimated Study Completion Date: December 2018
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TC

Cyclophosphamide 600 mg/m² D1 Docetaxel 75 mg/m² D1

1 cycle = 21 days TC*6 cycles

Drug: Docetaxel Cyclophosphamide

Docetaxel 75 mg/m² D1 Cyclophosphamide600 mg/m² D1

1 cycle = 21 days

TC*6

Other Name: FUDANCT1SH
Experimental: CEF-T

1st~3rd cycles 5-fluorouracil 500 mg/m2 Epirubicin 90 mg/m2 Cyclophosphamide 500 mg/m2

1 cycle=21 days

4th~6th cycles Docetaxel 100mg/m2

1 cycle=21 days CEF*3-T*3

Drug: Cyclophosphamide Fluorouracil Epirubicin Docetaxel

1st -3rd Cycle: Fluorouracil 500 mg/m² D1 Epirubicin 100 mg/m² D1 Cyclophosphamide 500 mg/m² D1

1 cycle = 21 days 4th-6th Cycle: Docetaxel 100mg/m² D1

1 cycle = 21 days CEF*3-T*3

Other Name: FUDANCT1SH
Experimental: EC-P

1st~4th cycles: Epirubicin 90 mg/m² D1 Cyclophosphamide 600 mg/m² D1

1 cycle = 21 days

5th-8th cycles: Paclitaxel 80mg/m² D1,D8,D15

1 cycle = 21 days

EC*4-P*4

Drug: Epirubicin Cyclophosphamide Paclitaxel

1st -4th Cycle: Epirubicin 90 mg/m² D1 Cyclophosphamide 600 mg/m² D1

1 cycle = 21 days 5th-8th Cycle: Paclitaxel 80mg/m² D1,8,15

1 cycle = 21 days EC*4-P*4

Other Name: FUDANCT1SH

Detailed Description:

Eligibility Female adults(> 18 years old) are eligible if they had histologically confirmed primary breast cancer. Patients also had Eastern Cooperative Oncology Group(ECOG) Performance status of 0 or 1, absolute neutrophil count (ANC)> 1500/mm3, hemoglobin > 8.0g/dL, and platelet count > 100,000/mm3, creatinine < 2.5 times the upper limit of normal(ULN)), transaminases < 2.5 times ULN or alkaline phosphatase < 4 times ULN if transaminases was normal, and total bilirubin < 2.5 times ULN. Exclusion criteria were active infection, pregnancy, other primary malignancy (except in situ carcinoma of cervix or adequately treated nonmelanomatous carcinoma of the skin), any documented distant metastasis and uncontrolled systemic diseases.

This study protocol was approved by institutional ethic review boards and conducted according to guidelines for good clinical practice and the Helsinki Declaration. All patients provided written informed consent.

Outcome Measures Primary Endpoint:5 year Disease Free Survival(DFS) Second Endpoints:5 year distant disease free survival (DDFS) 5year event free survival (EFS) 5year overall survival (OS)

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women aged from 40 to 65 years old;
  2. Histologically proven invasive unilateral breast cancer (regardless of the type);
  3. Initial clinical condition compatible with complete initial resection;
  4. No residual macro or microscopic tumor after surgical excision;
  5. Beginning of chemotherapeutic treatment no later than day 42 after the initial surgery;
  6. Node positive disease (positive sentinel node or positive axillary clearance) (N+) or node negative disease (N-) with the following criteria : SBR II / III and pT > 20 mm;
  7. Patient presenting one of the following criteria (reviewed before randomization by referent pathologist):Luminal A, Luminal B,Her-2 overexpressed Hormone receptor negativity is defined as ER<10%, PR<10% (IHC), HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH negative].
  8. No clinically or radiologically detectable metastases (M0);
  9. No peripheral neuropathy > 1;
  10. WHO Performance status (ECOG) of 0 or 1;
  11. Adequate recovery from recent surgery (at least one week must have elapsed from the time of a minor surgery (excluding breast biopsy); at least three weeks for major surgery);
  12. Adequate hematological function (neutrophil count ³ 2x109/l, platelet count ³ 100x 109/l, Hemoglobin > 9 g/dl);
  13. Adequate hepatic function: ASAT and ALAT £ 1.5 ULN alkaline phosphatases £ 2.5 ULN,total bilirubin £ 1,5 ULN;
  14. Adequate renal function: serum creatinine £ 1.5 ULN;
  15. Patients accepting contraception intake during the overall length of treatment if of childbearing potential;
  16. Adequate cardiac function, LEVF value > 50% by Muga scan or echocardiography;
  17. Signed written informed consent.

Exclusion Criteria:

  1. Bilateral breast cancer or patient with controlateral DCIS;
  2. Any metastatic impairment, including homolateral sub-clavicular node involvement,regardless of its type;
  3. Any tumor ³ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer);
  4. Triple negative (ER-PR-Her-2-)
  5. Any clinically or radiologically suspect and non-explored damage to the controlateral breast;
  6. Any chemotherapy, hormonal therapy or radiotherapy before surgery;
  7. Previous cancer (excepted cutaneous baso-cellular epithelioma or uterine peripheral epithelioma) in the preceding 5 years, including invasive controlateral breast cancer;
  8. Patients already included in another therapeutic trial involving an experimental drug;
  9. Patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study;
  10. LEVF < 50% (MUGA scan or echocardiography);
  11. Clinically significant cardiovascular disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension (> 150/90), myocardial infarction or cerebral vascular accidents) within 6 months prior to randomization;
  12. Known prior severe hypersensitivity reactions to agents containing Cremophor EL;
  13. Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 8 weeks after treatment completion;
  14. Women who are pregnant or breastfeeding. Adequate birth control measures should be taken during study treatment phase;
  15. Women with a positive pregnancy test en enrollment or prior to study drug administration;
  16. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
  17. Individual deprived of liberty or placed under the authority of a tutor.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314833

Locations
China, Shanghai
Feifei
Shanghai, Shanghai, China
Sponsors and Collaborators
Fudan University
Chinese Anti-Cancer Association
  More Information

No publications provided

Responsible Party: Chinese Anti-Cancer Association,Committee Breast Cancer Society, Chinese Anti-Cancer Association
ClinicalTrials.gov Identifier: NCT01314833     History of Changes
Other Study ID Numbers: Fudan BC Adjuvant CT1
Study First Received: March 9, 2011
Last Updated: March 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Fudan University:
Luminal A
Luminal B
Her-2 overexpression
DFS
DDFS
OS

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Docetaxel
Epirubicin
Fluorouracil
Paclitaxel
Alkylating Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 23, 2014