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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier:
NCT00432172
First received: February 6, 2007
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Standard treatment
Drug: Selective treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: "A Randomized Multicenter Phase II Trial to Evaluate the Effectiveness of Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients"

Resource links provided by NLM:


Further study details as provided by Spanish Breast Cancer Research Group:

Primary Outcome Measures:
  • Response rate [ Time Frame: After surgey. ] [ Designated as safety issue: No ]

    Pathological response (basal group): pathological response will be assessed after surgery, according to the scale of Miller & Payne.

    Clinical Response:

    will be evaluated the clinical response to treatment according to the model established by the RECIST Group. (Response Evaluation Criteria in Solid Tumors).



Enrollment: 189
Study Start Date: September 2007
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1 (Luminal A) QT
Standard treatment
Drug: Standard treatment
EC x 4 -> Tx4
Experimental: Group 1 (Luminal A) HT
Selective treatment
Drug: Selective treatment
Postmenopausic patients: exemestane x 6 months; Premenopausic Patients: goserelin x 6 months + exemestane x 6 months
Active Comparator: Group 2 (Basal) Standard treatment
Standard treatment
Drug: Standard treatment
ECx4-> Tx4
Experimental: Group 2 (Basal) Selective treatment Drug: Selective treatment
EC x4->CBPT x4

Detailed Description:

Group 1 (Luminal A):

  • Standard treatment: EC x 4 -> Tx4
  • Selective treatment: Postmenopausic patients: exemestane x 6 months; Premenopausic Patients: goserelin x 6 months + exemestane x 6 months

Group 2 (Basal):

  • Standard treatment: EC x 4 -> Tx4
  • Selective treatment: EC x 4 -> CDPT x 4
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent.
  • Breast cancer with histological diagnosis.
  • Negative HER2neu tumours(defined as 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); SGOT and SGPT <= 2.5xUNL; alkaline phosphatase <= 2.5xUNL.
  • Adequate renal function: creatinine <= 1xUNL; 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:

  • HER2neu positive tumours (defined as IHQ 3+ or positive 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 [NCI CTC]).
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432172

Locations
Spain
Spanish Breast Cancer Research Group (GEICAM)
San Sebastián de los Reyes, Madrid, Spain, 28703
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Pfizer
Investigators
Study Chair: Antonio Antón, MD., PhD. Spanish Breast Cancer Research Group (GEICAM)
  More Information

Additional Information:
No publications provided

Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT00432172     History of Changes
Other Study ID Numbers: GEICAM/2006-03
Study First Received: February 6, 2007
Last Updated: November 21, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Breast Cancer Research Group:
Her2neu negative breast cancer.
Neoadjuvant treatment.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014