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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00432172
Recruitment Status : Completed
First Posted : February 7, 2007
Results First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Epirubicin Drug: Cyclophosphamide Drug: Docetaxel Drug: Exemestane Drug: Goserelin Drug: Carboplatin Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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"
Actual Study Start Date : April 24, 2007
Actual Primary Completion Date : September 1, 2010
Actual Study Completion Date : September 1, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.
Drug: Epirubicin
Other Name: Ellence

Drug: Cyclophosphamide
Other Name: Cytoxan

Drug: Docetaxel
Other Name: Taxotere

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

Drug: Exemestane
Other Name: aromasil

Drug: Goserelin
Other Name: Zoladex

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.
Drug: Epirubicin
Other Name: Ellence

Drug: Cyclophosphamide
Other Name: Cytoxan

Drug: Docetaxel
Other Name: Taxotere

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.
Drug: Epirubicin
Other Name: Ellence

Drug: Cyclophosphamide
Other Name: Cytoxan

Drug: Docetaxel
Other Name: Taxotere

Drug: Carboplatin
Other Name: Paraplatin




Primary Outcome Measures :
  1. Pathological Response for Basal Group 2 [ Time Frame: Up to 24 weeks ]
    This primary outcome only applies for the basal group 2 as per protocol. The pathological response in luminal group 1 was not pre-specified even as a Secondary Outcome. Pathological response was assessed after surgery, according to the Miller & Payne criteria, which stratifies the responses based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in breast and axilla. Grades 1-4 are categorised as a partial pathological response (pPR) and grade 5 was a complete pathological response (cPR).


Secondary Outcome Measures :
  1. Clinical Response Rate [ Time Frame: Up to week 24 ]
    Clinical Response Rate was measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria for target lesions before surgery: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  2. Breast Conservative Surgery Rate [ Time Frame: Up to 24 weeks ]
    All patients will undergo surgery within the expected period from the end of treatment with neoadjuvant therapy. The chosen surgical option will be collected in the Case Report Form (CRF) before starting the neoadjuvant treatment, depending on the characteristics Clinics of the patient at that time (conservative surgery or mastectomy). This information will be compared with definitive surgery, to analyze whether neoadjuvant treatment has contributed to increase the rate of conservative surgery.

  3. Axillary Node Status at the Time of Surgery [ Time Frame: Up to 24 weeks ]

    All the patients underwent lymphadenectomy in the foreseen term from the end of the treatment with neoadjuvant therapy, except for patients who underwent the technique of Sentinel lymph node with negative result before the start of the study treatment.

    Clinical lymph node involvement were collected in the CRF. Behind the lymphadenectomy, the rate of patients with affected lymph nodes, regardless of the type of response in the breast. To help find out if the cancer has spread outside the breast, one or more of the lymph nodes in the axilla (axillary lymph nodes) are removed for examination under a microscope. This is an important part of the determination of the stage. When the lymph nodes have cancer cells, there is a greater chance that the cancer cells have spread to other parts of the body. Decisions about treatment will depend on whether there is cancer in the lymph nodes.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00432172


Locations
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Spain
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, Spain, 08208
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221
Onkologikoa
Donostia, Gipuzkoa, Spain, 20014
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain, 15006
Centro Oncológico Regional de Galicia
A Coruña, Spain, 15009
Hospital General de Alicante
Alicante, Spain, 03010
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004
Complejo Hospitalario de Jaén
Jaén, Spain, 23007
Hospital de la Princesa
Madrid, Spain, 28006
Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain, 29010
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Pfizer
Investigators
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Study Director: Study Director Hospital Universitario Miguel Servet
Additional Information:
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Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT00432172    
Other Study ID Numbers: GEICAM/2006-03
First Posted: February 7, 2007    Key Record Dates
Results First Posted: July 17, 2019
Last Update Posted: July 17, 2019
Last Verified: May 2019
Keywords provided by Spanish Breast Cancer Research Group:
Her2neu negative breast cancer.
Neoadjuvant treatment.
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Carboplatin
Docetaxel
Epirubicin
Exemestane
Goserelin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Estrogen Antagonists