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Standard Chemotherapy Followed by Capecitabine as Prolonged Postoperative Adjuvant Treatment for Breast Cancer

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. Identifier: NCT02842099
Recruitment Status : Unknown
Verified July 2016 by Qiang SUN, Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : July 22, 2016
Last Update Posted : July 22, 2016
Information provided by (Responsible Party):
Qiang SUN, Peking Union Medical College Hospital

Brief Summary:
The study is a prospective, randomized phase II clinical trial, to compare the efficacy and safety profiles of standard chemotherapy versus standard chemotherapy followed by capecitabine as prolonged postoperative adjuvant treatment for breast cancer patients.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: TA or TAC Drug: X Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Phase II Study Comparing Standard Chemotherapy (TA-Taxol+Epirubicin or TAC-Taxol+Epirubicin+Cyclophosphamide) With Standard Chemotherapy (TA or TAC) Followed by Capecitabine (X) as Prolonged Postoperative Adjuvant Treatment for Breast Cancer
Study Start Date : January 2014
Estimated Primary Completion Date : January 2020

Arm Intervention/treatment
Experimental: TA or TAC plus X
Standard chemotherapy (TA or TAC) followed by capecitabine 2.5g, po, qd for one year.
Drug: TA or TAC
Taxol, Epirubincin, with or without Cyclophosphamide

Drug: X

Active Comparator: TA or TAC
Standard chemotherapy (TA or TAC) followed by no more chemotherapy
Drug: TA or TAC
Taxol, Epirubincin, with or without Cyclophosphamide

Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 5 years ]
  2. Adverse event rate (CTCAE v. 3.0) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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

Inclusion Criteria:

  • Age >= 18 and <= 70 years old.
  • Performance status (Karnofsky index) >= 80.
  • Histological diagnosis of invasive breast cancer (T1-T4,N2-3,M0). Time window between surgery and study randomization must be less than 60 days.
  • Surgery must consist of mastectomy or conserving surgery with axillary lymph node dissection.
  • Positive axillary lymph nodes defined as at least 1 out of 10 nodes with presence of disease. If sentinel node technique is used, sentinel node can be the only node affected.
  • Status of hormone receptors, HER2 status, Ki-67 index and p53 in primary tumour. Results must be available before the adjuvant chemotherapy. All patients require the TA or TAC chemotherapy. And patients should receive the endocrine chemotherapy or anti-targeted therapy according to the hormone receptor status or HER2 status respectively.
  • Written informed consent. Patients are able to comply with treatment and study follow-up.
  • Patients must not present evidence of metastatic disease.
  • Normal electrocardiogram (EKG) in the 12 weeks prior to randomization. If needed, normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF).
  • Laboratory results (within 14 days prior to randomization):
  • Hematology: neutrophils >= 2.0x10^9/l; platelets >= 100x10^9/l; hemoglobin >= 10 mg/dl;
  • Hepatic function: total bilirubin <= 1 upper normal limit (UNL); SGOT and SGPT <= 2.5 UNL; alkaline phosphatase <= 2.5 UNL. If values of SGOT and SGPT > 1.5 UNL are associated to alkaline phosphatase > 2.5 UNL, patient is not eligible;
  • Renal function: creatinine <= 175 mmol/l (2 mg/dl); creatinine clearance >= 60 ml/min.
  • Complete stage workup during the 12 weeks prior to randomization (mammograms are allowed within a 20 week window). All patients must have a bilateral mammogram, thorax x-ray, abdominal echography and/or computed tomography (CT)-scan. If bone pain, and/or alkaline phosphatase elevation, a bone scintigraphy is mandatory. This test is recommended for all patients. Other tests: as clinically indicated.
  • Negative pregnancy test done in the 14 prior days to randomization.

Exclusion Criteria:

  • Prior systemic therapy for breast cancer.Or prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.
  • Prior radiotherapy for breast cancer.
  • Bilateral invasive breast cancer.
  • Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments.
  • Any N0-1 or M1 tumour.
  • Pre-existing grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria version 2.0 [NCI CTC v-2.0]).
  • Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled HA or high risk arrhythmias.
  • History of neurological or psychiatric disorders, which could preclude the patients from free informed consent.
  • Active uncontrolled infection.
  • Active peptic ulcer; unstable diabetes mellitus.
  • Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumour curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.
  • Chronic treatment with corticosteroids.
  • Contraindications for corticosteroid administration.
  • Concomitant treatment with raloxifene, tamoxifen or other selective estrogen receptor modulators (SERMs), either for osteoporosis treatment or for prevention. These treatments must stop before randomisation.
  • Concomitant treatment with other investigational products; participation in other clinical trials with a non-marketed drug in the 20 previous days before randomization.
  • Concomitant treatment with another therapy for cancer.
  • Males.

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 identifier (NCT number): NCT02842099

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Contact: Yan Lin, Doctor 86-010-69152701

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China, Beijing
Dept. Breast Surgery, PUMCH Recruiting
Beijing, Beijing, China, 100730
Contact: Yan Lin, Doctor    +86-10-69152700   
Sponsors and Collaborators
Peking Union Medical College Hospital
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Responsible Party: Qiang SUN, Chief of Dept. Breast Surgery, Professor, Peking Union Medical College Hospital Identifier: NCT02842099    
Other Study ID Numbers: PUMCH-BREAST-X prolong therapy
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases