Koltuk Altı Lenf Bezi Tutulumu Olmayan Yüksek Riskli Meme Kanseri Hastalarında FAC ile FAC + Haftalık Paklitaksel Karşılaştırması (Adjuvan Tedavi)

Sade dilde özet

Bu çalışma, koltuk altı lenf bezlerine yayılmamış (node-negative) ama yüksek riskli meme kanseri hastalarında ameliyat sonrası (adjuvan) FAC kemoterapisi ile FAC + haftalık paklitaksel tedavisini karşılaştırıyor. HER2 negatif, ameliyat edilebilir tümörü olan hastalar dahil edilmiştir. Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Tamamlandı

Sponsor

Spanish Breast Cancer Research Group

Müdahale

Fluorouracil, Doxorubicin, Cyclophosphamide, Paclitaxel

Başlangıç

19.09.2003

Tahmini bitiş

01.10.2013

Ülkeler

Spain

İlgili genler

Merkezler

• Elche, Spain
• Elda, Spain
• Manresa, Spain
• Sabadell, Spain
• Santa Coloma de Gramenet, Spain
• Terrassa, Spain
• Terrassa, Spain
• Jerez de la Frontera, Spain
• Castellon, Spain
• Barbastro, Spain
• Las Palmas de Gran Canaria, Spain
• Alcorcón, Spain
• Boadilla del Monte, Spain
• Móstoles, Spain
• El Palmar, Spain
• Vigo, Spain
• San Cristóbal de La Laguna, Spain
• Reus, Spain
• Alzira, Spain
• A Coruña, Spain
• A Coruña, Spain
• Albacete, Spain
• Alicante, Spain
• Alicante, Spain
• Badalona, Spain
• Barcelona, Spain
• Barcelona, Spain
• Barcelona, Spain
• Barcelona, Spain
• Barcelona, Spain
• Bilbao, Spain
• Burgos, Spain
• Cadiz, Spain
• Ciudad Real, Spain
• Córdoba, Spain
• Cuenca, Spain
• Girona, Spain
• Guadalajara, Spain
• Jaén, Spain
• Lugo, Spain

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Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Written informed consent.
* Histological diagnoses of operable invasive adenocarcinoma of the breast (T1-T3). Tumors must be Human Epidermal Growth Factor Receptor 2 (HER2) negative. Patients must be free of disease in the axilla (node negative). If lymphadenectomy is done, at least 10 nodes must be examined. If sentinel node technique is used, sentinel node must be free of disease. Patients must present at least one high risk criterion (St. Gallen, 1998) as follows:

  * Tumor size \> 2 cm; and/or
  * ER and Progesterone Receptor (PgR) negative; and/or
  * Histological grade 2-3; and/or
  * Age \< 35 years old.
* Time window between surgery and study randomization must be less than 60 days.
* Surgery must consist of mastectomy or conservative surgery. Margins free of disease and ductal carcinoma in situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.
* Patients must not present evidence of metastatic disease.
* Status of hormone receptors in primary tumor. Results must be available before the end of adjuvant chemotherapy.
* Status of HER2 in primary tumor, known before randomization. Patients with Immunohistochemistry (IHC) 0 or +1 are eligible. For patients with IHC 2+, fluorescent in situ hybridization (FISH) is mandatory and result must be negative.
* Age \>= 18 and \<= 70 years old.
* Performance status (Karnofsky index) \>= 80.
* 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 \>= 100x 10\^9/l; hemoglobin \>= 10 mg/dl;
  * Hepatic function: total bilirubin \<= 1 upper normal limit (UNL); Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \<= 2.5 UNL; alkaline phosphatase \<= 2.5 UNL. If values of AST and ALT \> 1.5 UNL are associated with 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 time 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 previous 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. Negative pregnancy test in the 14 previous days to randomization.
* Any T4 or N1-3 or M1 tumor.
* HER2 positive breast cancer (IHC 3+ or positive FISH result).
* Pre-existing grade \>=2 motor or sensorial neurotoxicity by the National Cancer Institute Common Toxicity Criteria (NCICTC) v-2.0.
* Any other serious medical pathology, such as congestive heart failure, unstable angina, history of myocardial infarction during the previous year, uncontrolled hypertension or high risk arrhythmias.
* History of neurological or psychiatric disorders, which could preclude the patients to 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 tumor curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.
* 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 other therapy for cancer.
* Males.