- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02842099
Standard Chemotherapy Followed by Capecitabine as Prolonged Postoperative Adjuvant Treatment for Breast Cancer
July 21, 2016 updated by: Qiang SUN, Peking Union Medical College Hospital
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
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Dept. Breast Surgery, PUMCH
-
Contact:
- Yan Lin, Doctor
- Phone Number: +86-10-69152700
- Email: birds90@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TA or TAC plus X
Standard chemotherapy (TA or TAC) followed by capecitabine 2.5g, po, qd for one year.
|
Taxol, Epirubincin, with or without Cyclophosphamide
Capecitabine
|
Active Comparator: TA or TAC
Standard chemotherapy (TA or TAC) followed by no more chemotherapy
|
Taxol, Epirubincin, with or without Cyclophosphamide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease-free survival
Time Frame: 5 years
|
5 years
|
Adverse event rate (CTCAE v. 3.0)
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Anticipated)
January 1, 2020
Study Registration Dates
First Submitted
July 17, 2016
First Submitted That Met QC Criteria
July 21, 2016
First Posted (Estimate)
July 22, 2016
Study Record Updates
Last Update Posted (Estimate)
July 22, 2016
Last Update Submitted That Met QC Criteria
July 21, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUMCH-BREAST-X prolong therapy
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Ohio State University Comprehensive Cancer CenterCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Stage III Breast CancerUnited States
Clinical Trials on TA or TAC
-
Allergy TherapeuticsBencard Allergie GmbHActive, not recruitingAllergic Conjunctivitis | Allergic Asthma | Allergic Rhinitis Due to PollenGermany
-
Mitsubishi Tanabe Pharma CorporationCompletedType 2 Diabetes MellitusJapan
-
Universidad Catolica de TemucoUnknown
-
Taro Pharmaceuticals USACompleted
-
Mitsubishi Tanabe Pharma CorporationCompletedType 2 Diabetes MellitusJapan
-
Peking Union Medical College HospitalCompleted
-
Mitsubishi Tanabe Pharma CorporationCompletedBehcet Syndrome | Behcet's Disease | Neuro-Behcet's DiseaseJapan
-
Xention LtdCompleted