Clinical trial NCT04666805: Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With HR+ Intraductal Carcinoma of the Breast
Official title: Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With Hormone Receptor-positive Intraductal Carcinoma of the Breast: A Multicenter, Retrospective, Real-world Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: breast cancer
hormone receptor
aromatase inhibitor
recurrence
metastasis
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
Collaborators: name: The First Hospital of Jilin University
name: Second Hospital of Jilin University
name: Jilin Provincial Tumor Hospital
name: The Affiliated Zhongshan Hospital of Dalian University
name: The First Affiliated Hospital of Dalian Medical University
name: China-Japan Union Hospital, Jilin University
name: The Second Affiliated Hospital of Dalian Medical University
name: The Fifth People's Hospital of Shenyang
name: General Hospital of Benxi Steel & Iron (Group) Co., Ltd
name: Affiliated Hospital of Hebei University of Engineering
name: Fourth People's Hospital of Shenyang
First posted: 2020-12-14
Enrollment: 1354
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with hormone receptor-positive ductal carcinoma of the breast

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.

Detailed description: Intraductal carcinoma of the breast accounts for 20% of newly diagnosed breast cancer. In addition to necessary surgical treatment, 5-year endocrine therapy is also essential for patients with hormone receptor positive ductal carcinoma of the breast. Commonly used drugs include selective estrogen receptor modulators (Tamoxifen, Toremifene) and aromatase inhibitors (Exemestane, Anastrozole, Letrozole). Although these drugs can effectively reduce the recurrence and metastasis of ductal carcinoma of the breast, the adverse reactions of the above drugs significantly reduce the quality of life and treatment compliance of the patients. Therefore, the choice of endocrine therapy for intraductal carcinoma of the breast has been widely discussed. Is it possible for de-escalation of endocrine treatment intensity to reduce adverse reactions and improve patient compliance? Recently, a phase 3 clinical trial found that compared with placebo group, the adverse reactions of Tamoxifen group treated with 5 mg/d (conventional dose 20 mg/d) Tamoxifen for 3 years had less adverse reactions and achieved significant efficacy. This study revealed the reliable efficacy and safety of Tamoxifen, a low-dose drug for treatment of hormone receptor positive intraductal carcinoma of the breast. However, little is reported on the reasonable duration of Aromatase inhibitors for endocrine therapy in patients with intraductal carcinoma of the breast.

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.

Eligibility criteria: Inclusion Criteria:

* (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:

  1. Histologically confirmed intraductal carcinoma of the breast, accompanied by microinvasion, with the infiltration range ≤ 1 mm;
  2. Have received radical resection or breast conserving surgery;
  3. 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;
  4. No lymph node metastasis (including micrometastasis) is detected by postoperative pathological examination;
  5. Immuno
  6. 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

Exclusion Criteria:

* (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

Primary outcomes:
measure: Disease-free survival up to 16 years
timeFrame: Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years
measure: Invasive disease-free survival up to 16 years
timeFrame: Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years
measure: Distant disease-free survival up to 16 years
timeFrame: Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years
Secondary outcomes:
measure: Overall survival up to 16 years
timeFrame: Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years
Other outcomes:
measure: Adverse events of endocrine therapy up to 16 years
timeFrame: Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years
Locations:
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Bo Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: