Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients

NCT00432172

Last updated date
Study Location
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, 08208, Spain
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Written informed consent.

- Breast cancer with histological diagnosis.

- Negative Human Epidermal Growth Factor Receptor 2 (HER2) tumours defined as immunohistochemistry (IHQ) 0,1+.

- No evidence of suspicion of metastatic disease.

- Age >= 18 years old.

- Performance status (Karnofsky index) >= 80 (ECOG 0,1).

- Adequate cardiac function by ECG in the previous 12 weeks.

- Hematology: neutrophils >= 1,5 x10^9/l; platelets >= 100 x10^9/l; hemoglobin >= 10 g/dl.

- Adequate hepatic function: total bilirubin <= 1x Upper Normal Limit (UNL); Aspartate aminotransferase (AST) (SGOT) and Alanine aminotransferase (ALT) (SGPT) <= 2.5 x UNL; alkaline phosphatase <= 2.5 x UNL.

- Adequate renal function: creatinine <= 1 x UNL; creatinine clearance >= 60 ml/min.

- Patients able to comply with study treatment and follow-up.

- Negative pregnancy test in the previous 14 days.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- HER2 positive tumours (defined as IHQ 3+ or positive fluorescence in situ
hybridization [FISH]).


- Prior systemic therapy for breast cancer (immunotherapy, hormonotherapy,
chemotherapy).


- Prior treatment with anthracyclines or taxanes (paclitaxel, docetaxel) for any
previous malignancy.


- Prior radiotherapy for breast cancer.


- Bilateral invasive breast cancer.


- Pregnant or lactating women.


- Previous grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common
Toxicity Criteria [NCICTC]).


- Other serious comorbidities: congestive heart failure or unstable angina; prior
history of myocardial infarction in previous year; uncontrolled hypertension (HT);
high risk arrhythmias; history of significant neurological or psychiatric disorders;
uncontrolled active infection; active peptic ulcer; unstable diabetes mellitus;
dyspnea at rest; or chronic therapy with oxygen.


- Previous or current history of neoplasms different from breast cancer, except for skin
carcinoma, cervical in situ carcinoma, or any other tumor 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 administration of corticosteroids.


- Concomitant treatment with other therapy for cancer.


- Males.

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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients
Official Title  ICMJE "A Randomized Multicenter Phase II Trial to Evaluate the Effectiveness of Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients"
Brief Summary This is an open-label study that includes two substudies of random distribution. First,a sample of the primary tumor will be obtained and will be analyzed by an immunohistochemical technique to determine several markers.Depending on the expression of these markers, the patients will be characterize as group 1 (Luminal A phenotype) or group 2 (Basal phenotype) and a random assignment will be performed to standard or experimental treatment.
Detailed Description

Group 1 (Luminal A):

  • Standard treatment: Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.

EC x 4 -> D x 4

  • Selective treatment: Postmenopausal patients: exemestane x 6 months; Premenopausal patients: goserelin x 6 months + exemestane x 6 months

Group 2 (Basal):

  • Standard treatment: EC x 4 -> D x 4
  • Selective treatment: E 90 mg/ m2 iv in combination with C 600 mg/ m2 iv every 21 days for 4 cycles, followed by D (75 mg/m2) and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.

EC x 4 -> DCb x 4

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Epirubicin
    Other Name: Ellence
  • Drug: Cyclophosphamide
    Other Name: Cytoxan
  • Drug: Docetaxel
    Other Name: Taxotere
  • Drug: Exemestane
    Other Name: aromasil
  • Drug: Goserelin
    Other Name: Zoladex
  • Drug: Carboplatin
    Other Name: Paraplatin
Study Arms  ICMJE
  • Active Comparator: Group 1 (Luminal A) Standard treatment
    Standard treatment: Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.
    Interventions:
    • Drug: Epirubicin
    • Drug: Cyclophosphamide
    • Drug: Docetaxel
  • Experimental: Group 1 (Luminal A) Selective treatment

    Selective treatment:

    Postmenopausal patients: exemestane x 6 months Premenopausal patients: goserelin x 6 months + exemestane x 6 months

    Interventions:
    • Drug: Exemestane
    • Drug: Goserelin
  • Active Comparator: Group 2 (Basal) Standard treatment
    Standard treatment: Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.
    Interventions:
    • Drug: Epirubicin
    • Drug: Cyclophosphamide
    • Drug: Docetaxel
  • Experimental: Group 2 (Basal) Selective treatment
    Selective treatment: Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.
    Interventions:
    • Drug: Epirubicin
    • Drug: Cyclophosphamide
    • Drug: Docetaxel
    • Drug: Carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2011)
189
Original Enrollment  ICMJE
 (submitted: February 6, 2007)
188
Actual Study Completion Date  ICMJE September 1, 2010
Actual Primary Completion Date September 1, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent.
  • Breast cancer with histological diagnosis.
  • Negative Human Epidermal Growth Factor Receptor 2 (HER2) tumours defined as immunohistochemistry (IHQ) 0,1+.
  • No evidence of suspicion of metastatic disease.
  • Age >= 18 years old.
  • Performance status (Karnofsky index) >= 80 (ECOG 0,1).
  • Adequate cardiac function by ECG in the previous 12 weeks.
  • Hematology: neutrophils >= 1,5 x10^9/l; platelets >= 100 x10^9/l; hemoglobin >= 10 g/dl.
  • Adequate hepatic function: total bilirubin <= 1x Upper Normal Limit (UNL); Aspartate aminotransferase (AST) (SGOT) and Alanine aminotransferase (ALT) (SGPT) <= 2.5 x UNL; alkaline phosphatase <= 2.5 x UNL.
  • Adequate renal function: creatinine <= 1 x UNL; creatinine clearance >= 60 ml/min.
  • Patients able to comply with study treatment and follow-up.
  • Negative pregnancy test in the previous 14 days.

Exclusion Criteria:

  • HER2 positive tumours (defined as IHQ 3+ or positive fluorescence in situ hybridization [FISH]).
  • Prior systemic therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).
  • Prior treatment with anthracyclines or taxanes (paclitaxel, docetaxel) for any previous malignancy.
  • Prior radiotherapy for breast cancer.
  • Bilateral invasive breast cancer.
  • Pregnant or lactating women.
  • Previous grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria [NCICTC]).
  • Other serious comorbidities: congestive heart failure or unstable angina; prior history of myocardial infarction in previous year; uncontrolled hypertension (HT); high risk arrhythmias; history of significant neurological or psychiatric disorders; uncontrolled active infection; active peptic ulcer; unstable diabetes mellitus; dyspnea at rest; or chronic therapy with oxygen.
  • Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumor 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 administration of corticosteroids.
  • Concomitant treatment with other therapy for cancer.
  • Males.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00432172
Other Study ID Numbers  ICMJE GEICAM/2006-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spanish Breast Cancer Research Group
Study Sponsor  ICMJE Spanish Breast Cancer Research Group
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Study DirectorHospital Universitario Miguel Servet
PRS Account Spanish Breast Cancer Research Group
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP