Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03397537 |
| Other study ID # |
20170811 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
December 25, 2017 |
| Last updated |
January 14, 2018 |
| Start date |
September 2012 |
| Est. completion date |
July 2017 |
Study information
| Verified date |
September 2012 |
| Source |
Guangdong General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study aimed to compare the duration to complete or partial response (CR/PR) and the
overall response rates (ORR) after six months of neoadjuvant endocrine therapy between
pre-menopausal group and post-menopausal group with highly endocrine responsive operable
mammary carcinoma.
Description:
Estrogen receptor (ER) positive constitutes about 75% of all breast cancer(BC). Neoadjuvant
endocrine therapy(NET) plays an important part in primary therapy of the hormone receptor
(HR) -positive and HER2 -negative breast cancer. Recent studies revealed that the
third-generation aromatase inhibitors (AIs) have superior ORR than tamoxifen in the
HR-positive BC post-menopausal patients. The Z1031 trial showed that Letrozole obtained
better ORR than the other two AIs anastrozole and exemestane after 16-18 weeks NET, although
without any statistically significance.
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.
