AX Versus AC as Adjuvant Treatment for Node-Negative Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Peking Union Medical College Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01415336
First received: August 9, 2011
Last updated: August 10, 2011
Last verified: August 2011
  Purpose

Capecitabine has shown high efficacy in metastatic and adjuvant settings. This is a prospective, randomised trial, to compare the efficacy and safety profiles of capecitabine-containing regimen with non- capecitabine-containing adjuvant chemotherapy regimens for node negative breast cancer patients.


Condition Intervention Phase
Breast Cancer
Drug: Doxorubicin, Cyclophosphamide
Drug: doxorubicin, Capecitabine
Phase 2
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: AX (Doxorubicin, Capecitabine) Versus AC (Doxorubicin, Cyclophosphamide) as Adjuvant Treatment for Node-Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • disease-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Adverse event rate (CTCAE v. 3.0) [ Time Frame: 3 years and 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: March 2010
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AC
doxorubicin 60 mg/m², iv, day 1 Cyclophosphamide 600 mg/m², iv, day 1 every 3 weeks for 4 cycles
Drug: Doxorubicin, Cyclophosphamide
doxorubicin 60 mg/m², iv, day 1; Cyclophosphamide 600 mg/m², iv, day 1; every 3 weeks for 4 cycles
Experimental: AX
doxorubicin 60 mg/m², iv, day 1 capecitabine 950 mg/m2, twice a day, via oral intake, day 1 to day 14 every 3 weeks for 4 cycles
Drug: doxorubicin, Capecitabine
doxorubicin 60 mg/m², iv, day 1; capecitabine 950 mg/m2, twice a day, via oral intake, day 1 to day 14; every 3 weeks for 4 cycles

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent.
  • Histological diagnosis of operable invasive adenocarcinoma of the breast Tumours must be node negative. Time window between surgery and study randomization must be less than 60 days.
  • Surgery must consist of mastectomy or conservative surgery with axillary lymph node dissection. Margins free of disease and ductal carcinomas in situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.
  • Status of hormone receptors in primary tumour. Results must be available before the end of adjuvant chemotherapy.
  • Patients must not present evidence of metastatic disease. Status of HER2 in primary tumour, known before randomization.
  • Age >= 18 and <= 70 years old.
  • Performance status (Karnofsky index) >= 70.
  • 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 >= 1.5 x 10^9/l; platelets >= 100 x 10^9/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.
  • Patients able to comply with treatment and study follow-up.
  • Negative pregnancy test done in the 14 prior days to randomization.

Exclusion Criteria:

  • Prior systemic therapy for breast cancer.
  • Prior therapy with anthracyclines or capecitabine 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 M1 tumour.
  • Lymph node positive breast cancer.
  • 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.
  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: NCT01415336

Contacts
Contact: Qiang Sun, Master 86-010-88068936 sunq@medmail.com.cn
Contact: Songjie Shen, Doctor 86-010-88068936 pumcssj@163.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Qiang Sun, Master    86-010-88068936    sunq@medmail.com.cn   
Contact: Songjie Shen, Doctor    86-010-88068936    pumcssj@163.com   
Principal Investigator: Qiang Sun, Master         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Study Chair: Qiang Sun, Master PUMCH
  More Information

No publications provided

Responsible Party: Qiang Sun, the department of breast surgery of PUMCH
ClinicalTrials.gov Identifier: NCT01415336     History of Changes
Other Study ID Numbers: PUMCH-Breast- AX
Study First Received: August 9, 2011
Last Updated: August 10, 2011
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Liposomal doxorubicin
Capecitabine
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on August 28, 2014