Investigation of the clinical effects of combination therapy using LH-RH analogue + Anastrozole on patients with hormone receptor positive, premenopausal advanced/recurrent breast cancer resistant to combination therapy using LH-RH analogue + Tamoxife

Phase 2

• Conditions: Premenopausal breast cancer

• Registration Number: JPRN-UMIN000001217
• Lead Sponsor: The Japan-Multinational Trial Organization

Brief Summary

ONCOLOGY REPORT Vol: 29 No: 5 1707-1713 (May 2013). Title: Efficacy of goserelin plus anastrozole in premenopausal women with advanced or recurrent breast cancer refractory to an LH-RH analogue with tamoxifen: Results of the JMTO BC08-01 phase II trial. Results: Between September 2008 and November 2010, 37 patients were enrolled. Thirty-five patients (94.6%) had ER-positive tumors, and 36 (97.3%) had human epidermal growth factor receptor (HER) 2-negative tumors. Thirty-six (97.3%) had measurable lesions and 1 (2.7%) had only bone metastasis. The ORR was 18.9% [95% confidence interval (CI), 8.0-35.2%], the CBR was 62.2% (95% CI, 44.8-77.5%) and the median PFS was 7.3 months. Eight patients had adverse drug reactions but none resulted in discontinuation of treatment. GOS plus ANA is a safe effective treatment for premenopausal women with hormone receptor-positive, recurrent or advanced breast cancer. The treatment may become viable treatment in the future, particularly when TAM is ineffective or contraindicated. Further studies and discussion are warranted.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-29
• Study Completion: 2011-11-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Patients falling under any of the following 1.Patients with a history of drug allergy against the test drug and co-administered drug 2.Patients administered another anticancer drug since the prior treatment [LH-RHa + TAM therapy or LH-RHa + TAM followed by TAM therapy] 3.Patients receiving ongoing systemic administration [orally or intravenously] of an adrenal cortex hormone 4.Patients with advanced cancer in another organ less than 5 years after the completion of treatment 5.Patients with a history of thrombotic disease such as deep vein thrombosis or cerebral infarction 6.Patients with a history of severe heart disease such as myocardial infarction, valvular heart disease or heart failure 7.Patients receiving administration of HRT for treatment of menopausal symptoms within 4 weeks of registration 8.Women who are pregnant, lactating or may be [intend to be] pregnant 9.Patients planning treatment with an anticancer drug other than LH-RHa + Anastrozole, a bisphosphonate or radiation therapy on a target lesion following the start of this trial 10.Other cases who the doctor responsible for the trial judges unsuitable

Study & Design

• Study Type: Interventional
• Study Design: Not specified