Study Results
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Basic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2012-09-30
2017-07-31
Brief Summary
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Detailed Description
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In spite of these findings, the optimal duration of NET has not been fully elaborated, Although prolonged treatment might further reduce the tumor size. Further clinical benefits were achieved when the period of treatment of neoadjuvant letrozole prolonged more than three to four months. The 2015 St. Gallen International Consensus Conference recommended continuing neoadjuvant therapy in highly hormone-sensitive breast cancer for a minimum of 4-8 months. However, most studies aim to identify the excellent efficacy of the AIs compared with other drugs but not the duration of NET therapy. Antonio et al. suggest that the time to maximum clinical efficacy may be the optimal period of treatment for the patients; And the median time to maximum efficacy was 4.2 months (95% CI, 4.0-4.5). The present study evaluated the time to CR/PR and the ORR after 6 months of NET.
Previous clinical studies investigating NET mainly focused on post-menopausal women, data on pre-menopausal women is still relatively lacking due to the widely perception that more benefit may be achieved from neoadjuvant chemotherapy (NCT) among younger patients. The result of Z1031 trial showed superiority of neoadjuvant of AIs and promoted wider application of AIs as NET in the HR-positive post-menopausal women, and the clinical response rate (CRR) of letrozole was 74.8% after 16-18 weeks of treatment. The combination of AIs and GnRH analogue may be alternative for selected pre-menopausal patients. The STAGE trial showed the overall response rates of anastrozole plus goserelin in pre-menopausal patients was 70.4% after 6 months of NET. However, studies comparing the ORR and optimal duration of NET between pre-menopausal and post-menopausal patients were rare.
The purpose of the our research was to compare the duration to CR/PR and the ORR after 6 months of NET between pre-menopausal and post-menopausal women with highly endocrine responsive operable BC.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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the postmenopausal
2.5 mg letrozole every day for six months
Letrozole 2.5Mg Tablet
letrozole 2.5mg p.o.qd
the premenopausal
2.5 mg letrozole daily along with a GnRH analogue for ovarian suppression, which was administered as an intramuscular injection of 3.75 mg triptorelin every 28 days for 6 months.
Letrozole 2.5Mg Tablet
letrozole 2.5mg p.o.qd
GnRH analogue
3.75 mg triptorelin im. q28d
Interventions
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Letrozole 2.5Mg Tablet
letrozole 2.5mg p.o.qd
GnRH analogue
3.75 mg triptorelin im. q28d
Eligibility Criteria
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Inclusion Criteria
2. ER-positive (≥50%), PgR-positive (≥50% ), HER2-negative, and previously untreated, non-metastatic primary invasive BC.
3. The tumour size had to be \>1 cm.
Exclusion Criteria
2. patients with inflammatory breast cancer or distant metastasis;
3. patients who were previously treatment treated with chemotherapy, radiation therapy or prior treatment with AIs or antiestrogens for breast cancer;
4. patients with a second concomitant neoplasm;
5. patients who could not meet the eligibility criteria.
18 Years
FEMALE
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
Responsible Party
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Locations
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Minyi Cheng
Guanzhou, Guangdong, China
Countries
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Other Identifiers
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20170811
Identifier Type: -
Identifier Source: org_study_id
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