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

NCT04666805 | Unknown DMC

• 1 other identifier: FirstHCMU_CB_001
• Study Type: observational
• Target: 1,354
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

breast cancer; hormone receptor; aromatase inhibitor; recurrence; metastasis

Outcome Measures

Primary Outcomes (3)

• Disease-free survival up to 16 years

  Disease-free survival refers to the time from the first disease-free day (i.e. the operation day) to the day at which relevant event occurs.

  Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years

• Invasive disease-free survival up to 16 years

  Invasive disease-free survival refers to the time from the first disease-free day (i.e. the operation day) to the day at which intraductal carcinoma of the breast recurs. The recurrent diseases include ipsilateral or contralateral breast cancer, local and distant recurrence of breast cancer, and death due to any reason.

  Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years

• Distant disease-free survival up to 16 years

  Distant disease-free survival refers to the time from the first disease-free day (i.e. the operation day) to the day at which distant metastasis occurs.

  Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years

Secondary Outcomes (1)

• Overall survival up to 16 years

  Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years

Other Outcomes (1)

• Adverse events of endocrine therapy up to 16 years

  Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years

Study Arms (1)

Drug Group

Endocrine therapy drugs include selective estrogen receptor modulators (Tamoxifen, Toremifene) and aromatase inhibitors (Anastrozole, Letrozole, Exemestane), which have been widely used in the adjuvant treatment of hormone receptor positive breast cancer.

Drug: Tamoxifen; Drug: Toremifene; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane

Interventions

Tamoxifen DRUG

20 mg/d, oral administration

Drug Group

Toremifene DRUG

60 mg/d, oral administration

Drug Group

Anastrozole DRUG

1 tablet (1 mg) per day, oral administration

Drug Group

Letrozole DRUG

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 Group

Exemestane DRUG

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.

Drug Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with hormone receptor-positive ductal carcinoma of the breast

You may qualify if:

• (1)Female patients aged ≥ 18 years and ≤ 85 years
• (2)The primary lesions and lymph nodes of the breast must meet all of the following conditions:
• Histologically confirmed intraductal carcinoma of the breast, accompanied by microinvasion, with the infiltration range ≤ 1 mm;
• Have received radical resection or breast conserving surgery;
• Patients who have received breast conserving surgery must undergo pathological examination to confirm there is no residual cancer tissue on the cutting edge and receive postoperative radiotherapy within the prescribed dose and range;
• No lymph node metastasis (including micrometastasis) is detected by postoperative pathological examination;
• Immuno
• Immunohistochemical staining results are positive for estrogen receptor (ER) or progesterone receptor (PR), which is defined as ER or PR immunoreactivity intensity ≥1+ or expression percentage ≥ 1%.
• (3)A volunteer to participate in the study and willing to cooperate with follow-up

You may not qualify if:

• (1)Patients with newly diagnosed metastatic breast cancer or other malignant tumors without breast intraductal carcinoma;
• (2) Patients who have other malignant tumors before the initial diagnosis of intraductal carcinoma of the breast
• (3) Patients who have received endocrine therapy with drugs including Toremifene, Tamoxifen, Anastrozole, Letrozole or Exemestane before the initial diagnosis of intraductal carcinoma of the breast
• (4) Patients who have a serious comorbidity or other comorbidities that interfere with the conduct of the study, or those who are considered not suitable for participation in this study

Sponsors & Collaborators

• First Hospital of China Medical University: lead
• The First Hospital of Jilin University: collaborator
• Second Hospital of Jilin University: collaborator
• Jilin Provincial Tumor Hospital: collaborator
• Affiliated Zhongshan Hospital of Dalian University: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• China-Japan Union Hospital, Jilin University: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• The Fifth People's Hospital of Shenyang: collaborator
• General Hospital of Benxi Steel & Iron (Group) Co., Ltd: collaborator
• Affiliated Hospital of Hebei University of Engineering: collaborator
• Fourth People's Hospital of Shenyang: collaborator

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Recurrence; Neoplasm Metastasis

Interventions

Tamoxifen; Toremifene; Anastrozole; Letrozole; exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bo Chen, MD

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 14, 2020
• Study Start: July 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 15, 2021
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

CN (1)