Letrozole in Treating Breast Cancer in Postmenopausal Women With Stage I, II, or III Breast Cancer Previously Treated With Tamoxifen (GIM4)

Launched by IRCCS AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO - IST ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO, GENOA, ITALY · Feb 5, 2010

Keywords

ClinConnect Summary

This clinical trial, called the GIM4 study, is looking at how effective a medication called letrozole is for treating breast cancer in postmenopausal women. Specifically, it focuses on women who have early to moderately advanced breast cancer (stages I, II, or III) and who have already been treated with another medication called tamoxifen. Letrozole works by reducing the amount of estrogen in the body, which can help slow down or stop the growth of breast cancer cells that rely on estrogen.

To participate in the trial, women need to be postmenopausal and have had a confirmed diagnosis of breast cancer at stages I to III. They should have received tamoxifen for at least two years but no more than three years and three months. Participants can expect to be randomly assigned to different treatment plans using letrozole. The trial is currently active but not recruiting new participants. It's also important to note that certain medical conditions and previous treatments may affect eligibility, so interested individuals should discuss their specific situation with their doctor.

Gender

FEMALE

Eligibility criteria

• • INCLUSION CRITERIA
• • Signed informed consent prior to beginning protocol specific procedures.
• • Histologically proven breast cancer at the first diagnosis with tumor stage I-II-III. Patients with histologically documented (microscopic) infiltration of the skin (pT4) will also be eligible.
• • Axillary Nodal status allowed: Nx, pNo, pN1, pN2, pN3.
• * Postmenopausal status defined by one of the following:
• • Age \> 55 years with cessation of menses
• • Age \< 55 years but not spontaneous menses for at least 1 year
• • Age \< 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (e.g. spontaneous, or secondary to hysterectomy), AND with postmenopausal gonadotrophin levels (luteinizing hormone and follicle stimulating hormone levels \>40 IU/L) or postmenopausal estradiol levels (\<5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved.
• • Bilateral oophorectomy
• • Adjuvant TAM received for at least 2 years and not more than 3 years and 3 months. Patients treated with adjuvant chemotherapy, are required to have begun receiving TAM within 3 months after the completion of chemotherapy.
• • Definitive surgical treatment must be either mastectomy or breast conserving surgery, with axillary lymph node dissection or sentinel node biopsy for operable breast cancer.
• • ECOG/WHO performance Status 0-1. Patients must be accessible for treatment and follow-up.
• • Concomitant treatment with biphosphonates are allowed and should be recorded during the trial.
• • EXCLUSION CRITERIA
• • Male patients.
• • Any locally advanced (T4) or inflammatory breast cancer. However, patients with microscopic infiltration of the skin (pT4) will be eligible.
• • Patients with distant metastases. Any suspicious manifestation requires appropriate investigation to exclude metastases.
• • Histology other than adenocarcinoma.
• • Patients with previous or concomitant (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for 5 years.
• • Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.
• • Use of hormone Replacement Therapy within four weeks before randomization.
• • Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational regimen within 30 days prior to study entry.
• • Concurrent treatment with any other anti-cancer therapy.