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

AX (Doxorubicin, Capecitabine) Versus AC (Doxorubicin, Cyclophosphamide) as Adjuvant Treatment for Node-Negative Breast Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Doxorubicin, Cyclophosphamide; Drug: doxorubicin, Capecitabine

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Principal Investigator: Qiang Sun, Master
      • Contact: Qiang Sun, Master; Phone Number: 86-010-88068936; Email: sunq@medmail.com.cn
      • Contact: Songjie Shen, Doctor; Phone Number: 86-010-88068936; Email: pumcssj@163.com

Participation Criteria

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
disease-free survival	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	5 years
Adverse event rate (CTCAE v. 3.0)	3 years and 5 years

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: Qiang Sun, Master, PUMCH

Publications and helpful links

General Publications

• Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: August 9, 2011
• First Submitted That Met QC Criteria: August 10, 2011
• First Posted (Estimate): August 11, 2011

Study Record Updates

• Last Update Posted (Estimate): August 11, 2011
• Last Update Submitted That Met QC Criteria: August 10, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Capecitabine; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: PUMCH-Breast- AX