Microarray Analysis in breast cancer to Taylor Adjuvant Drugs Or Regimens, a randomized phase III study

Not Applicable

Completed

• Conditions: Breast cancer; Cancer; Breast

• Registration Number: ISRCTN61893718
• Lead Sponsor: etherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)

Brief Summary

2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29371927 results (added 16/01/2019) 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30125761 results (added 16/01/2019) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39206149/ (added 02/09/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Study Completion: 2012-11-19
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 664

Inclusion Criteria

Current inclusion criteria as of 29/04/2013:
1. Women with pT1-T3, pN0-3b, M0 adenocarcinoma of the breast (TNM classification 2002). Women with a macrometastasis in the sentinel node, who did not receive an axillary dissection (pN1(sn)), are only eligible if radiotherapy of the axilla is included in the treatment plan (for instance experimental arm AMAROS study);
2. Known HER2 and estrogen receptor status.
3. Frozen tumor tissue available (or tumor tissue sent in RNAlater to NKI-AVL).
4. primary surgery (defined as date of last surgical intervention) < 6 weeks before randomisation, or radiotherapy < 5 weeks before randomisation.
5. Good performance status (WHO < 1)
6. normal hematology, normal renal and liver function tests (see below).
7. no history of heart failure.
8. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment (chemotherapy and hormonal therapy).
9. no conditions that may compromise follow-up.
10. informed consent.
11. At least 18 years old and able to undergo intensive chemotherapy (in the study of Martin et al. employing the TAC regimen (1d) age < 65 years was required).
12. Laboratory requirements: (within 14 days prior to registration)
12.1. Hematology:
12.1.1. Neutrophils = 1.5 109/L;
12.1.2. Platelets = 100 109/L;
12.1.3. Hemoglobin =6.0 mmol/L;
12.2. Hepatic function:
12.2.1. Total bilirubin = 16 umol/L;
12.2.2. ASAT (SGOT) and ALAT (SGPT) = 1.5 UNL;
12.2.3. Alkaline phosphatase = 2.5 UNL;
12.3. Renal function:
12.3.1. Creatinine = 120 µmol/L;
12.3.2. If limit values, the calculated creatinine clearance should be = 60 mL/min.

Previous inclusion criteria until 29/04/2013:
1. Women with pT0-T3, pN 1-3b, M0 adenocarcinoma of the breast (TNM classification 2002). Women with a macrometastasis in the sentinel node, who did not receive an axillary dissection (pN1(sn)), are only eligible if radiotherapy of the axilla is included in the treatment plan (for instance experimental arm AMAROS study).
2. Frozen tumor tissue available (or tumor tissue sent in RNAlater to NKI-AVL)
3. Primary surgery <6 weeks before randomisation, or radiotherapy <5 weeks before randomisation
4. Good performance status; WHO <1
5. Normal hematology, normal renal and liver function tests (see below)
6. No history of heart failure
7. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment (chemotherapy and hormonal therapy)
8. No conditions that may compromise follow-up
9. Written Informed consent
10. Able to undergo intensive chemotherapy (in the study of Nabholtz (1) age <65 years was required)
11. Laboratory requirements: (within 14 days prior to registration)
Hematology:
i. Neutrophils >1.5 x 10^9/l
ii. Platelets >100 x 10^9/l
iii. Hemoglobin >6.0 mmol/l
Hepatic function:
i. Total bilirubin <16 µmol/L
ii. ASAT (SGOT) and ALAT (SGPT) <1.5 UNL
iii. Alkaline phosphatase <2.5 UNL
Renal function:
i. Creatinine <120 µmol/l
ii. If limit values, the calculated creatinine clearance should be >60 ml/min

Exclusion Criteria

Current exclusion criteria as of 29/04/2013:
1. Prior systemic anticancer therapy for any cancer (immunotherapy, hormonal therapy, chemotherapy)
2. Prior radiation therapy for breast cancer
3. HER2 positive breast cancer (except for patients who are going to be treated according to HERA study (1c)
4. Pregnant, or lactating patients
5. Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by NCI criteria
6. Other serious illness or medical condition:
6.1. Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias
6.2. History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
6.3. Active uncontrolled infection
7. Past history of invasive breast cancer or past or current history of neoplasm other than breast carcinoma, except for:
7.1. Curatively treated non-melanoma skin cancer
7.2. In situ carcinoma of the cervix
7.3. Ipsilateral ductal carcinoma in-situ (DCIS) of the breast
7.4. Lobular carcinoma in-situ (LCIS) of the breast
8. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry
9. Male patients

Previous exclusion criteria until 29/04/2013:
1. Prior systemic anticancer therapy for any cancer (immunotherapy, hormonal therapy, chemotherapy)
2. Prior radiation therapy for breast cancer
3. Pregnant, or lactating patients
4. Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by NCI criteria
5. Other serious illness or medical condition:
5.1 Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias
5.2 A history of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
5.3 Active uncontrolled infection
6. Past or current history of neoplasm other than breast carcinoma, except for:
6.1 Curatively treated non-melanoma skin cancer
6.2 In situ carcinoma of the cervix, cipsilateral ductal carcinoma in-situ (DCIS) of the breast,
6.3 Llobular carcinoma in-situ (LCIS) of the breast
7. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
8. Male patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcomes as of 29/04/2013:<br>To define gene expression profiles that can predict a disease-free survival (DFS) advantage for either dose dense therapy, or docetaxel?containing chemotherapy.<br><br>Previous primary outcomes until 29/04/2013:<br>To define gene expression profiles that can predict a disease-free survival advantage for either dose dense therapy, docetaxel, and/or 6 versus 4 courses of chemotherapy.