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Adjuvant 6 Cycles of Docetaxel and Cyclophosphamide or 3 Cycles of Cyclophosphamide/Epirubicin/Fluorouracil Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Epirubicin and Cyclophosphamide Followed by Weekly Paclitaxel in Operable Breast Cancer (MATTER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04127019
Recruitment Status : Completed
First Posted : October 15, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Zhimin Shao, Fudan University

Brief Summary:
We aimed to evaluate the noninferiority of a short-term anthracycline-free chemotherapy (TC, six cycles of docetaxel and cyclophosphamide) or a short-term anthracycline-based chemotherapy (CEF-T, three cycles of cyclophosphamide/epirubicin/fluorouracil followed by three cycles of docetaxel) to a standard anthracycline/taxane-containing chemotherapy (EC-P, epirubicin and cyclophosphamide for four cycles followed by paclitaxel for twelve weeks) in operable breast cancer.

Condition or disease Intervention/treatment Phase
Primary Breast Cancer Drug: Paclitaxel Drug: Docetaxel Drug: Cyclophosphamide Drug: epirubicin Drug: 5-fluorouracil Phase 3

Detailed Description:
It was initiated as an adjuvant chemotherapy trial in 2010 to test noninferiority of an anthracycline-free short-term regimen (T75C600 x 6 [TC] once every 3 weeks) or a short-term regimen (C500E100F500 x 3 once every 3 weeks followed by T100 x 3 every 3 weeks [CEF-T]) compared with a standard long-term anthracycline-containing regimen (E90C600 x 4 once every 3 weeks followed by P80 x 12 once every week [EC-P]). Patients were randomly assigned (1:1:1) to each arm after completing surgical excision of primary tumor. Trastuzumab was administered in combination with chemotherapy to patients with HER2-positive breast cancer and sustained monotherapy to 12 months

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2079 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Experimental: Arm 1 6 cycles of (Docetaxel 75mg/m2 ivgtt d1+ Cyclophosphamide 600 mg/m2 iv d1, 21 days per cycle) .

Experimental: Arm 2 3 cycles of FEC (epirubicin 100 mg/m2 ivgtt d1+Cyclophosphamide 500 mg/m2 iv d1+ 5-fluorouracil 500 mg/m2 iv d1, 21 days per cycle) followed by 3 cycles of Docetaxel (Docetaxel 100mg/m2, ivgtt d1, 21 days per cycle)

Experimental: Arm 3 4 cycles of EC (epirubicin 90 mg/m2 ivgtt d1+Cyclophosphamide 600 mg/m2 iv d1+ , 21 days per cycle) followed by 4 cycles of Paclitaxel (Paclitaxel 80mg/m2, ivgtt d1,8,15, 21days per cycle).

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Six Cycles of Docetaxel and Cyclophosphamide or Three Cycles of Cyclophosphamide/Epirubicin/Fluorouracil Followed by Three Cycles of Docetaxel Versus Four Cycles of Epirubicin and Cyclophosphamide Followed by Weekly Paclitaxel in Operable Breast Cancer
Actual Study Start Date : June 1, 2010
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: TC*6
6 cycles of (Docetaxel 75mg/m2 ivgtt d1+ Cyclophosphamide 600 mg/m2 iv d1, 21 days per cycle) .
Drug: Docetaxel
Docetaxel chemotherapy (injection)

Drug: Cyclophosphamide
Cyclophosphamide chemotherapy (injection)

Experimental: FEC*3-T*3
3 cycles of FEC (epirubicin 100 mg/m2 ivgtt d1+Cyclophosphamide 500 mg/m2 iv d1+ 5-fluorouracil 500 mg/m2 iv d1, 21 days per cycle) followed by 3 cycles of Docetaxel (Docetaxel 100mg/m2, ivgtt d1, 21 days per cycle)
Drug: Docetaxel
Docetaxel chemotherapy (injection)

Drug: Cyclophosphamide
Cyclophosphamide chemotherapy (injection)

Drug: epirubicin
Epirubicin chemotherapy (injection)

Drug: 5-fluorouracil
5-fluorouracil chemotherapy (injection)

Experimental: EC*4-wP*12
4 cycles of EC (epirubicin 90 mg/m2 ivgtt d1+Cyclophosphamide 600 mg/m2 iv d1+ , 21 days per cycle) followed by 4 cycles of Paclitaxel (Paclitaxel 80mg/m2, ivgtt d1,8,15, 21days per cycle).
Drug: Paclitaxel
Paclitaxel chemotherapy (injection)

Drug: Cyclophosphamide
Cyclophosphamide chemotherapy (injection)

Drug: epirubicin
Epirubicin chemotherapy (injection)




Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 5 year ]

Secondary Outcome Measures :
  1. distant metastasis free survival [ Time Frame: 5 year ]
  2. event free survival [ Time Frame: 5 year ]
  3. overall survival [ Time Frame: 5 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients, age at diagnosis 18 - 75 years
  • Histological confirmed unilateral primary invasive carcinoma of the breast
  • Adequate surgical treatment with complete resection of the tumor (R0) and resection of > or = 10 axillary nodes or SLN in clinically N0 patients
  • Node positive disease or node negative disease with at least one other risk factor (tumor size > or = 2 cm, grade > or = 2)
  • No evidence for distant metastasis (M0) after conventional staging
  • Performance Status ECOG < or = 1 or Kps> 80
  • The patient must be accessible for treatment and follow-up
  • LVEF> 50%
  • Negative pregnancy test (urine or serum) within 7 days prior to randomization in premenopausal patients
  • Leucocytes > or = 4 109/L
  • platelets > or = 100 109/L
  • haemoglobin > or = 9 g/dL
  • total bilirubin < or = 1.5 ULN
  • ASAT (SGOT) and ALAT (SGPT) < or = 2.5 UNL
  • creatinine < 175 ymol/L (2 mg/dL)

Exclusion Criteria:

  1. Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy);
  2. Has bilateral breast cancer;
  3. Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
  4. Has metastic (Stage 4) breast cancer;
  5. Has any >T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer);
  6. Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
  7. Patients participating in other clinical trials at the same time;
  8. Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) < 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
  9. Has known allergy to taxane and excipients.
  10. Has severe or uncontrolled infection;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04127019


Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Zhi-Ming Shao Fudan University

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Responsible Party: Zhimin Shao, professor, Fudan University
ClinicalTrials.gov Identifier: NCT04127019    
Other Study ID Numbers: MATTER
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Fluorouracil
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antimetabolites
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors