TAC Versus TCX as Adjuvant Treatment for Node-Positive Her2-Negative Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Docetaxel, Doxorubicin, Cyclophosphamide
Docetaxel, Cyclophosphamide, Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Written informed consent.
- Histological diagnosis of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 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.
- 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 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. Patients with immune histochemistry (IHC) 0 or +1 are eligible. For patients with ICH 2+, fluorescence in situ hybridization (FISH) is mandatory and result must be negative.
- 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 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 T4 or M1 tumour.
- HER2 positive breast cancer (IHC 3+ or positive FISH result).
- 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.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TAC
TCX
Arm Description
docetaxel 75 mg/m², iv, day 1 doxorubicin 50 mg/m² or epirubicin 75mg/m², iv, day 1 Cyclophosphamide 500 mg/m², iv, day 1 every 3 weeks for 6 cycles
docetaxel 75 mg/m², iv, day 1 Cyclophosphamide 500 mg/m², iv, day 1 capecitabine 950 mg/m2, twice a day, via oral intake, day 1 to day 14 every 3 weeks for 6 cycles
Outcomes
Primary Outcome Measures
disease-free survival
Secondary Outcome Measures
Overall survival
Adverse event rate (CTCAE v. 3.0)
Full Information
NCT ID
NCT01354522
First Posted
May 9, 2011
Last Updated
January 14, 2014
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01354522
Brief Title
TAC Versus TCX as Adjuvant Treatment for Node-Positive Her2-Negative Breast Cancer
Official Title
A Randomized, Phase III Study Comparing TAC (Docetaxel, Doxorubicin, Cyclophosphamide) With TCX ( Docetaxel, Cyclophosphamide, Capecitabine) as Adjuvant Treatment for Node-Positive Her2-Negative Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Some sub-analysis has shown anthracycline-based regimens are not effective in Her-2 negative breast cancer, while capecitabine is more effective in this group of patients.
This is a prospective, randomised phase III trial, to compare the efficacy and safety profiles of two types of adjuvant chemotherapy regimens for HER2 negative, node positive breast cancer patients.
Control Arm: This includes 6 cycles of TAC 75/50/500 mg/m2 day 1 every 3 weeks. Experimental Arm: This includes 6 cycles of TC 75/500 mg/m2, day 1 every 3 weeks, concurrently with capecitabine 950 mg/m2, twice a day, via oral intake, for 14 days, and then a one-week rest period.
Women with hormone receptor positive tumours must receive 5 years endocrine after the end of chemotherapy.
Patients may receive radiotherapy when clinically indicated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAC
Arm Type
Active Comparator
Arm Description
docetaxel 75 mg/m², iv, day 1 doxorubicin 50 mg/m² or epirubicin 75mg/m², iv, day 1 Cyclophosphamide 500 mg/m², iv, day 1 every 3 weeks for 6 cycles
Arm Title
TCX
Arm Type
Experimental
Arm Description
docetaxel 75 mg/m², iv, day 1 Cyclophosphamide 500 mg/m², iv, day 1 capecitabine 950 mg/m2, twice a day, via oral intake, day 1 to day 14 every 3 weeks for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxel, Doxorubicin, Cyclophosphamide
Intervention Description
docetaxel 75 mg/m², iv, day 1 doxorubicin 50 mg/m² or epirubicin 75mg/m², iv, day 1 Cyclophosphamide 500 mg/m², iv, day 1 every 3 weeks for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxel, Cyclophosphamide, Capecitabine
Intervention Description
docetaxel 75 mg/m², iv, day 1 Cyclophosphamide 500 mg/m², iv, day 1 capecitabine 950 mg/m2, twice a day, via oral intake, day 1 to day 14 every 3 weeks for 6 cycles
Primary Outcome Measure Information:
Title
disease-free survival
Time Frame
3 years and 5 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
5 years
Title
Adverse event rate (CTCAE v. 3.0)
Time Frame
3 years and 5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent.
Histological diagnosis of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 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.
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 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. Patients with immune histochemistry (IHC) 0 or +1 are eligible. For patients with ICH 2+, fluorescence in situ hybridization (FISH) is mandatory and result must be negative.
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 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 T4 or M1 tumour.
HER2 positive breast cancer (IHC 3+ or positive FISH result).
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Sun, Master
Phone
86-010-88068936
Email
sunq@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Songjie Shen, Doctor
Phone
86-010-88068936
Email
pumcssj@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Sun, Master
Organizational Affiliation
PUMCH
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Sun, Master
Phone
86-010-88068936
Email
sunq@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Songjie Shen, Doctor
Phone
86-010-88068936
Email
pumcssj@163.com
First Name & Middle Initial & Last Name & Degree
Qiang Sun, Master
12. IPD Sharing Statement
Citations:
PubMed Identifier
34037241
Citation
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.
Results Reference
derived
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TAC Versus TCX as Adjuvant Treatment for Node-Positive Her2-Negative Breast Cancer
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