scholarly journals 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

2013 ◽  
Vol 29 (5) ◽  
pp. 1707-1713 ◽  
Author(s):  
REIKI NISHIMURA ◽  
KEISEI ANAN ◽  
YUTAKA YAMAMOTO ◽  
KENJI HIGAKI ◽  
MAKI TANAKA ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Premenopausal Women ◽  
Recurrent Breast Cancer ◽  
Recurrent Breast ◽  
Lh Rh

A multicenter phase II trial of the LH-RH analogue and an aromatase inhibitor combination in premenopausal patients with advanced or recurrent breast cancer refractory to an LH-RH analogue with tamoxifen: JMTO BC08-01.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 588-588 ◽  
Author(s):  
Reiki Nishimura ◽  
Keisei Anan ◽  
Yutaka Yamamoto ◽  
Kenji Higaki ◽  
Maki Tanaka ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Bone Metastasis ◽  
Aromatase Inhibitor ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Recurrent Breast Cancer ◽  
Endocrine Treatment ◽  
Premenopausal Patients ◽  
Recurrent Breast ◽  
Lh Rh

588 Background: The aim was to provide an endocrine therapy option against advanced (ABC) or recurrent breast cancer (RBC) in premenopausal women. We conducted an exploratory phase II trial in combination with an LH-RH analogue (LH-RHa) and an aromatase inhibitor (AI) to assess the efficacy and tolerability after failure of standard LH-RHa plus tamoxifen (TAM). Methods: Premenopausal patients (pts) with ER+ and/or PgR+ ABC or RBC refractory to LH-RHa + TAM were treated with LH-RHa (goserelin: GOS) and AI (anastrozole: ANA). The primary endpoint was an objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), clinical benefit rate (CBR) based on RECIST, and safety assessed using CTCAE ver. 3.0. Pts with only bone legions were assessed using the criteria by Japanese Breast Cancer Society (14th Ed.). Local assessment (CR, PR or long SD of 24 weeks or longer) was confirmed independently by two radiologists. Results: Between September 2008 and November 2010, 37 pts were enrolled at 10 clinical institutions in Japan. Eleven had recurrence either during, or within one year after the end of adjuvant GOS + TAM (including GOS + TAM followed by only TAM). The disease progressed in 26 women during GOS + TAM. Mean age and BMI were 43.5 years and 22.2 kg/m2, respectively. Thirty-five pts (94.6%) were ER+, and 36 pts (97.3%) were HER2- (one with unknown HER2 status). Non-endocrine treatment included chemotherapy (20 pts; 54%) and radiation therapy (13 pts; 35%). The viscera, soft tissue, and bones were treated in 17, 15 and 14 pts, respectively. Pts with both measurable lesions and bone metastasis, measurable lesions only, and only bone metastasis were 21 (57%), 15 (41%) and 1 (2%), respectively. ORR was 18.9% (95%CI: 8.0-35.2%, 1 CR and 6 PR cases), CBR 62.2% (23 pts, 95%CI: 44.8-77.5%), and median PFS was 7.2 months. Eight pts (21.6%) had adverse events, but none resulted in treatment discontinuation. GOS + ANA was well tolerated. Conclusions: LH-RHa (GOS) + ANA can be a subsequent endocrine treatment for premenopausal pts with ABC or RBC after failure of GOS + TAM.

scholarly journals Phase II trial of eribulin and S-1 combination therapy for advanced or recurrent breast cancer

2017 ◽  
Vol 28 ◽  
pp. x28
Author(s):  
T. Iwasa ◽  
J. Tsurutani ◽  
Y. Mizuno ◽  
Y. Kojima ◽  
T. Takashima ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Combination Therapy ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Recurrent Breast Cancer ◽  
Recurrent Breast

Efficacy of doxifluridine combined with weekly paclitaxel therapy in the treatment of advanced or recurrent breast cancer: results of the JMTO BC01 phase II trial

2008 ◽  
Vol 19 (9) ◽  
pp. 911-915 ◽  
Author(s):  
Reiki Nishimura ◽  
Takeshi Tominaga ◽  
Morihiko Kimura ◽  
Yasuhiro Yanagita ◽  
Nobumitsu Tamaki ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Recurrent Breast Cancer ◽  
Weekly Paclitaxel ◽  
Recurrent Breast

scholarly journals Phase II trial of Eribulin/S-1 combination therapy for advanced/recurrent breast cancer

2016 ◽  
Vol 27 ◽  
pp. vii80
Author(s):  
Tsutomu Iwasa ◽  
Yoshifumi Komoike ◽  
Junji Tsurutani ◽  
Kazuhiko Nakagawa ◽  
Yutaka Mizuno ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Combination Therapy ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Recurrent Breast Cancer ◽  
Recurrent Breast

Phase II Trial of Anastrozole Plus Goserelin in the Treatment of Hormone Receptor–Positive, Metastatic Carcinoma of the Breast in Premenopausal Women

2010 ◽  
Vol 28 (25) ◽  
pp. 3917-3921 ◽  
Author(s):  
Robert. W. Carlson ◽  
Richard Theriault ◽  
Christine M. Schurman ◽  
Edgardo Rivera ◽  
Cathie T. Chung ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Antitumor Activity ◽  
Phase Ii ◽  
Hormone Receptor ◽  
Phase Ii Trial ◽  
Hot Flashes ◽  
Metastatic Breast ◽  
Premenopausal Women ◽  
Hormone Receptor Positive

Purpose To explore the antitumor activity of the aromatase inhibitor, anastrozole, in the treatment of premenopausal women with hormone receptor–positive, metastatic breast cancer who have been rendered functionally postmenopausal with the use of the luteinizing hormone-releasing hormone agonist, goserelin. Patients and Methods Premenopausal women with estrogen and/or progesterone receptor–positive, metastatic or recurrent breast cancer were enrolled in this prospective, single-arm, multicenter phase II trial. Patients were treated with goserelin 3.6 mg subcutaneous monthly and began anastrozole 1-mg daily 21 days after the first injection of goserelin. Patients continued on treatment until disease progression or unacceptable toxicity. Results Thirty-five patients were enrolled of which 32 were evaluable for response and toxicity. Estradiol suppression was assessed, with mean estradiol levels of 18.7 pg/mL at 3 months and 14.8 pg/mL at 6 months. One participant (3.1%) experienced a complete response, 11 (34.4%) experienced partial response, and 11 (34.4%) experienced stable disease for 6 months or longer for a clinical benefit rate of 71.9%. Median time to progression was 8.3 months (range, 2.1 to 63+) and median survival was not been reached (range, 11.1 to 63+). The most common adverse events were fatigue (50%), arthralgias (53%), and hot flashes (59%). There were no grade 4 to 5 toxicities. Conclusion The combination of goserelin plus anastrozole has substantial antitumor activity in the treatment of premenopausal women with hormone receptor–positive metastatic breast cancer.

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