Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With HR+ Intraductal Carcinoma of the Breast

Summary

This study will investigate the relationship between the endocrine therapy and the survival of patients with hormone receptor positive intraductal carcinoma of the breast, and the optimal duration of medication. This study will also analyze the risk factors of recurrence and metastasis of hormone receptor positive intraductal carcinoma of the breast and establish a prognosis model to further clarify the specific reasons for recurrence and metastasis, adverse reactions, and drug withdrawal in patients with hormone receptor positive intraductal carcinoma of the breast after endocrine therapy.

Conditions

• Breast Cancer

Interventions

DRUG

Tamoxifen

20 mg/d, oral administration

DRUG

Toremifene

60 mg/d, oral administration

DRUG

Anastrozole

1 tablet (1 mg) per day, oral administration

DRUG

Letrozole

Adjuvant therapy with letrozole for 5 years or until the disease relapses. Patients who have received tamoxifen adjuvant therapy for 5 years should continue to take Letrozole until the disease relapses. The recommended dose of Letrozole tablets is one 2.5 mg tablet administered once a day, without regard to meals. For patients with advanced breast cancer, treatment with Letrozole should continue until tumor progression is confirmed. Patients with liver and/or renal dysfunction (creatinine clearance rate ≥ 10 mL/min) do not need to adjust the dosage.

DRUG

Exemestane

The recommended dose of Exemestane for adult and older patients with early and advanced breast cancer is one 25 mg tablet administered orally once a day after a meal. After 2-3 years of tamoxifen treatment, patients with early breast cancer should continue to use Tamoxifen in the case of no recurrence or contralateral breast cancer, until the completion of 5-year sequential adjuvant therapy with tamoxifen and exemestane. Patients with advanced breast cancer should continue to take Exemestane until the tumor progresses.

Sponsors & Collaborators

• The First Hospital of Jilin University

  collaborator OTHER

• Second Hospital of Jilin University

  collaborator OTHER

• Jilin Provincial Tumor Hospital

  collaborator OTHER

• Affiliated Zhongshan Hospital of Dalian University

  collaborator OTHER

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• China-Japan Union Hospital, Jilin University

  collaborator OTHER

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• The Fifth People's Hospital of Shenyang

  collaborator UNKNOWN

• General Hospital of Benxi Steel & Iron (Group) Co., Ltd

  collaborator UNKNOWN

• Affiliated Hospital of Hebei University of Engineering

  collaborator UNKNOWN

• Fourth People's Hospital of Shenyang

  collaborator OTHER

• First Hospital of China Medical University

  lead OTHER

Principal Investigators

• Bo Chen, MD · First Hospital of China Medical University

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-01

Primary Completion

2021-01-01

Completion

2021-01-15

Countries

• China

Study Locations