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

NCT02842099 | Unknown Phase 2

• 1 other identifier: PUMCH-BREAST-X prolong therapy
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Disease-free survival

  5 years

• Adverse event rate (CTCAE v. 3.0)

  5 years

Secondary Outcomes (1)

• Overall survival

  5 years

Study Arms (2)

TA or TAC plus X

EXPERIMENTAL

Standard chemotherapy (TA or TAC) followed by capecitabine 2.5g, po, qd for one year.

Drug: TA or TAC; Drug: X

TA or TAC

ACTIVE COMPARATOR

Standard chemotherapy (TA or TAC) followed by no more chemotherapy

Drug: TA or TAC

Interventions

TA or TAC DRUG

Taxol, Epirubincin, with or without Cyclophosphamide

TA or TAC; TA or TAC plus X

X DRUG

Capecitabine

TA or TAC plus X

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Dept. Breast Surgery, PUMCH

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

1,4,7,10-tetraazacyclododecane-1,4,7-triacetic-10-methyl(4-aminobenzylphosphinic) acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yan Lin, Doctor

CONTACT

86-010-69152701; birds90@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Dept. Breast Surgery, Professor

Study Record Dates

• First Submitted: July 17, 2016
• First Posted: July 22, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2020
• Last Updated: July 22, 2016

Record last verified: 2016-07

Locations

CN (1)