Timing of Breast Cancer Surgery, Menstrual Cycle and Prognosis
conventional surgery
Maladies du sein+3
+ Néoplasmes
+ Néoplasmes par site
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 1999
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine if the timing of breast surgery during the menstrual cycle impacts disease recurrence, progression, or death among different racial groups in premenopausal women with stage I, II, or III breast cancer. Determine if definitive breast cancer surgeries (e.g., lumpectomy or mastectomy) performed during the follicular phase result in poorer prognosis (recurrence, disease progression, or death) compared with surgeries performed during the midcycle or luteal phases in this patient population. OUTLINE: This is a multicenter study. Patients undergo either fine needle aspiration concurrently with definitive breast surgery (mastectomy or lumpectomy) or needle-directed excisional biopsy followed by definitive breast surgery. Patients undergo serum collection for hormonal analysis preoperatively, 24 hours post operatively, at days 7 and 14, and at 3 months and urine collection for hormonal analysis beginning 24 hours prior to surgery and continuing daily until the onset of the next menses. Patients complete a 30-minute telephone interview regarding medical, family, occupational, and reproductive history and lifestyle habits (e.g., diet, exercise, or environmental exposures). Beginning 24 hours prior to surgery and continuing until the onset of the next menses, patients complete a menstrual cycle journal indicating the start and length of menses. Patients undergoing mastectomy are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. Patients undergoing adjuvant therapy are followed every 3 months for 3 years and then every 6 months thereafter or every 4 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study within 2.5 years.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: Histologically confirmed stage I, II, or III primary breast cancer undergoing breast surgery Invasive disease (e.g., lobular or ductal) No bilateral disease No distant metastases Premenopausal Regular menses (no amenorrhea of more than 90 days) without hormone replacement Documented last menstrual period Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: Premenopausal Sex: Female Menopausal status: See Disease Characteristics Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior malignancies Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No preoperative chemotherapy Endocrine therapy: No concurrent hormonal replacement therapy No concurrent interruptive oral contraceptive use of less than 3 months Radiotherapy: Not specified Surgery: See Disease Characteristics No prior hysterectomy and/or bilateral oophorectomy
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 2 sites
Rebecca and John Moores UCSD Cancer Center
La Jolla, United StatesOuvrir Rebecca and John Moores UCSD Cancer Center dans Google MapsJonsson Comprehensive Cancer Center, UCLA
Los Angeles, United States