Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Reproductive Control Agents

Tamoxifen

Hormones

Leuprolide

Goserelin

Aromatase Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Enzyme Inhibitors

Ovarian Suppression：Goserelin 3.6 mg or Leuprolide 3.75 mg administered intravenously every 28 days, for 5 years.

AI: no restriction of specific drugs, oral by standard dose of post-menopause breast cancer, for 5 years.

Ovarian Suppression：Goserelin 3.6 mg or Leuprolide 3.75 mg administered intravenously every 28 days, for 5 years.

Tamoxifen: 20mg oral for every day, for 5 years.

Lin Ying, doctor

Chen R Ping, bachelor

Ailing Zhang

Qianjun Chen

Zhang A Qin

Li Zhao

Hongming Ma

Yao H Rui

Yuan Z Yu

Lehong Zhang

Rui Zhuo

Li Cai

Weixiong Yang

Jingcai Zhong

Li J Wen

Zhang Y Qi

Huang Heng

Feihai Ling

Hongyu Zhang

The objective of this study is to compare the curative effects in patients under the age of 35 with hormone receptor positive breast cancer and high recurrent risk factors including large tumor or metastatic lymph nodes randomized to ovarian function suppression (OFS) plus aromatase inhibitors or OFS plus tamoxifen as adjuvant endocrine therapy, and explore the differences of curative effects between different subtypes to provide direct evidence for treatments of young breast cancer patients.

Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen in Young Women

Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen for Hormone Receptor-Positive Breast Cancer in Women Younger Than 35: A Multicenter Randomized Clinical Trial

DFS is defined as the time between randomization and the date of the first occurrence of events as follow: local, regional recurrence or distant metastasis of invasive breast cancer, contralateral invasive breast cancer, or death due to any diseases. Patients who have not had disease progression or death at the end of follow-up (5 years) will be censored at the date last known to be alive and distant metastasis free. Subgroup analysis DFS of Luminal A and Luminal B breast cancer.

The time from randomization to death due to any cause. Patients still alive at the end of follow-up (5 years) will be censored at the last known alive date.

The time between randomization and the first occurrence of local, regional recurrence or distant metastasis of invasive breast cancer, or contralateral invasive breast cancer. Patients who have not had invasive breast cancer recurrence at the end of follow-up (5 years) will be censored at the date last known to be distant metastasis free.

First Affiliated Hospital, Sun Yat-Sen University

Vice Director of Department of Breast Surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen in Young Women	NCT02914158	Breast Cancer	Goserelin Tamoxifen Aromatase Inhib... Leuprolide	- 35 Years	First Affiliated Hospital, Sun Yat-Sen University
Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen in Young Women	NCT02914158	Breast Cancer	Goserelin Tamoxifen Aromatase Inhib... Leuprolide	- 35 Years	First Affiliated Hospital, Sun Yat-Sen University

Spots Global Cancer Trial Database for ovarian function suppression (ofs)