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Trial record 59 of 99 for:    FEC

To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer

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ClinicalTrials.gov Identifier: NCT02846428
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the efficacy and safety of treatment with oral capecitabine or intravenous (IV) 5-fluorouracil (5-FU), in combination with epirubicin and cyclophosphamide, prior to surgery in participants with breast cancer. The participants will receive 4 cycles of neoadjuvant Capecitabine + Epirubicin + Cyclophosphamide (CEX) or 5-FU + Epirubicin + Cyclophosphamide (FEC 100) chemotherapy during first treatment period (Period 1, Days 1-85). After 4-6 weeks of the fourth cycle of neoadjuvant chemotherapy (Day 120 +/- 7 days), breast surgery with regional lymph node dissection will be performed, followed within a maximum of 6 weeks by the second treatment period (Period 2, Days 1 to 85) when participants in both study arms will receive 4 cycles of adjuvant docetaxel 100 milligrams per meter square (mg/m^2) by IV infusion on Day 1 of each 21-day cycle. Upon completion of the second treatment period, participants will enter the post-treatment follow-up period which will last for 5 years from the initial date of participant randomization. During this period participants will be evaluated once a year on the anniversary date of randomization.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: 5-Fluorouracil Drug: Capecitabine Drug: Cyclophosphamide Drug: Docetaxel Drug: Epirubicin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Randomized, Phase II Study to Evaluate the Efficacy and Safety of Two Combination Dose Regimens: Capecitabine + Epirubicin + Cyclophosphamide (CEX) Versus 5-FU + Epirubicin + Cyclophosphamide (FEC 100) as Neoadjuvant Therapy in Females Presenting With Operable Breast Cancer
Study Start Date : March 2004
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: 5-Fluorouracil + Epirubicin + Cyclophosphamide
Neoadjuvant treatment (Period 1): Participants will receive 4 cycles (cycle length = 21 days) of 5-FU + epirubicin + cyclophosphamide. Surgery will be performed 5 (+/- 1) weeks after the last cycle. Adjuvant treatment (Period 2): Participants will receive 4 cycles (cycle length = 21 days) of docetaxel.
Drug: 5-Fluorouracil
5-FU will be administered at 500 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle during neoadjuvant treatment period for 4 cycles.

Drug: Cyclophosphamide
Cyclophosphamide will be administered at 500 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.

Drug: Docetaxel
Docetaxel will be administered at 100 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles during adjuvant treatment period.

Drug: Epirubicin
Epirubicin will be administered at 100 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.

Experimental: Capecitabine + Epirubicin + Cyclophosphamide
Neoadjuvant treatment (Period 1): Participants will receive 4 cycles (cycle length = 21 days) of capecitabine + epirubicin + cyclophosphamide. Surgery will be performed 5 (+/- 1) weeks after the last cycle. Adjuvant treatment (Period 2): Participants will receive 4 cycles (cycle length = 21 days) of docetaxel.
Drug: Capecitabine
Capecitabine will be administered at 900 mg/m^2 orally twice daily on Days 1-14 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.
Other Name: Xeloda

Drug: Cyclophosphamide
Cyclophosphamide will be administered at 500 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.

Drug: Docetaxel
Docetaxel will be administered at 100 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles during adjuvant treatment period.

Drug: Epirubicin
Epirubicin will be administered at 100 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.




Primary Outcome Measures :
  1. Percentage of participants with pathological complete tumor response Assessed by Expert Blinded Independent Review according to the Sataloff classification\n [ Time Frame: Day 120 +/- 7 days ]

Secondary Outcome Measures :
  1. Percentage of participants with pathological complete tumor response Assessed by Investigator according to the Sataloff classification [ Time Frame: Day 120 +/- 7 days ]
  2. Percentage of participants with breast conserving surgery [ Time Frame: Day 120 +/- 7 days ]
  3. Percentage of participants with objective clinical response, assessed by World Health Organization (WHO) criteria [ Time Frame: Week 15 ]
  4. Percentage of participants with clinical response, assessed by WHO criteria [ Time Frame: Week 15 ]
  5. Percentage of participants with disease progression, assessed by WHO criteria [ Time Frame: Baseline up to 29 +/- 1 weeks ]
  6. Percentage of participants with abnormalities in bilateral mammography [ Time Frame: Day 85 ]
  7. Percentage of participants who died [ Time Frame: Baseline up to 29 +/- 1 weeks ]
  8. Percentage of participants with abnormal left ventricular ejection fraction (LVEF) [ Time Frame: Days 1-85 ]
  9. Percentage of participants with abnormal liver ultrasound [ Time Frame: Days 1-85 ]
  10. Percentage of participants with abnormal Chest X-Ray [ Time Frame: Days 1-85 ]
  11. Overall survival [ Time Frame: Baseline up to 5 years ]
  12. Disease free survival, according to WHO criteria [ Time Frame: Baseline up to 5 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females with a unilateral, non-inflammatory, non-multicentric, non-metastatic breast adenocarcinoma, not considered candidates for conservative management, and whose diagnosis had been histologically confirmed as T2-3, N0-1, M0 according to the tumor-nodes-metastasis (TNM) classification
  • Clinically or radiologically measurable lesion (in 2 dimensions)
  • Eastern Cooperative Oncology Group (ECOG) performance Status less than equal to (<=) 1

Exclusion Criteria:

  • Females presenting with brain metastases or a neurological or psychiatric disorder which could interfere with proper treatment compliance
  • Previous radiotherapy, chemotherapy, or hormonal therapy for breast cancer
  • Previous history of a malignancy in last 5 years other than cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix
  • Serious concomitant infection
  • Pregnant or lactating females

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): NCT02846428


Locations
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France
Bayonne, France, 64100
Beziers, France, 34500
Bourg En Bresse, France, 01012
Colmar, France, 68024
Dijon, France, 21079
Hyeres, France, 83400
La Tronche, France, 38700
Le Mans, France, 72037
Limoges, France, 87042
Lyon, France, 69437
Marseille, France, 13385
Montbeliard, France, 25209
Montfermeil, France, 93370
Nice, France, 06189
Nimes, France, 30029
Paris, France, 75181
Pierre Benite, France, 69310
Saint Herblain, France, 44805
Strasbourg, France, 67010
Toulouse, France, 31059
Vannes, France, 56001
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02846428     History of Changes
Other Study ID Numbers: ML16986
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016

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