A Study to Evaluate Exemestane Tablets Combined With Ovarian Function Suppression/Ablation in Treatment of Premenopausal Breast Cancer Patients With CYP2D6*10 Mutations (STEP)

NCT03137368

Last updated date
Study Location
CancerIHCAMS
Beijing, Beijing, 100010, China
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
CYP2D6 Polymorphism
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Providing informed consent forms voluntarily before screening evaluation;

- For Chinese premenopausal women, her estradiol level must be within the premenopausal level, or the patient meet the following 4 criteria in the prior 6 months: No chemotherapy, Regular menstruation, No use of hormonal, contraceptives, No use of hormone for treatment or for temporary amenorrhea caused by chemotherapy, the estradiol level tested within 8 months after the last dose of chemotherapeutics is within the premenopausal level;

- Patients with invasive breast cancer which has been confirmed by histological examination;

- Complete removal of tumor by surgery without local residual;

- Neoadjuvant chemotherapy before surgery is permitted if the surgery for primary breast cancer is performed within 12 weeks without any further adjuvant chemotherapy, or adjuvant chemotherapy is completed within 8 months;

- Estrogen receptor (ER) and/or progesterone receptor (PR) positive: If the patient has more than one breast tumor lesions, each tumor lesion should be ER and/or PR positive.

- Her-2 negative;

- Genotyping test performed by the central laboratory designated by sponsor with the results confirmed as CYP2D6*10T/T gene mutation.

- Women of childbearing age with negative serum pregnancy test result, and agreeing to adopt highly efficient non-hormonal contraception measure throughout the study;

- Subject without major organ dysfunction, and with normal heart, liver, kidney, lung and other major organ function.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Inflammatory breast cancer;


- Breast cancer patients with supraclavicular lymph nodes metastasis;


- Patients with enlarged internal mammary lymph nodes (except for patients with negative
pathologic findings);


- Ovariectomy which is not specified in the study;


- Patients with ovary protection during the chemotherapy;


- Concomitant use of other aromatase inhibitors (not Exemestane);


- Received major surgery which was unrelated to breast cancer within four weeks before
randomization, or the patients had not yet fully recovered from such surgery;


- Pregnant or lactating women;


- Known active hepatitis B or hepatitis C or HIV;


- Having difficulty in swallowing oral preparations and gastrointestinal dysfunction;


- Recently had severe and uncontrolled systemic diseases (e.g.: cardiovascular disease,
lung disease, or metabolic disease, venous thrombosis with clinical significance);


- Currently or previously suffering from other malignant tumors (except for skin basal
cell carcinoma or squamous cell carcinoma, carcinoma in situ of cervix which had been
fully treated), unless a radical treatment had been done with the evidence of
no-recurrence or metastasis in nearly five years;


- Allergic to any study drug or any ingredients of drug;


- Patient with poor compliance or other conditions which makes the patient unsuitable to
participate in this study judged by the investigator.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Exemestane Tablets Combined With Ovarian Function Suppression/Ablation in Treatment of Premenopausal Breast Cancer Patients With CYP2D6*10 Mutations ?STEP?
Official Title  ICMJE A Randomized Controlled Study to Evaluate Exemestane Tablets Combined With Ovarian Function Suppression/Ablation in Treatment of Premenopausal Breast Cancer Patients With CYP2D6*10 Mutations ?STEP?
Brief Summary This is a multicenter, randomized, open-label, parallel, active-controlled superiority clinical study conducted in early premenopausal estrogen-receptor positive breast cancer patients with CYP2D6*10 mutations. The efficacy and safety of Exemestane Tablets combined with ovarian function suppression/ablation and Tamoxifen Tablets combined with ovarian function suppression/ablation in the treatment of early premenopausal estrogen-receptor positive breast cancer patients with CYP2D6*10 mutations are compared.
Detailed Description

The target population for this study is early stage premenopausal estrogen-receptor positive breast cancer patients with CYP2D6*10 mutations. All the potential subjects must provide the informed consent. The subjects who provide the informed consent form (ICF) will enter the screening period, and will be evaluated for the eligibility.

This study expects to enroll 300 subjects, eligible subjects will be randomized at a ratio of 1:1 into treatment group (Exemestane Tablets combined with ovarian function suppression/ablation) or control group (Tamoxifen Tablets combined with ovarian function suppression/ablation).

The subjects who are assigned to treatment group will receive Exemestane Tablet combined with ovarian function suppression/ablation, Exemestane Tablets orally, once a day, one tablet each time (25 mg) and to be taken within 8 weeks from receiving ovarian function suppression treatment or after bilateral ovariectomy, and continue for 5 years or until endpoint event occurs. If the patients are not treated for 5 years because of adverse events (AE) or other reasons, the patient should be followed up until 5 years.

The subjects who are assigned to the control group will receive Tamoxifen Tablets combined with ovarian function suppression/ablation, Tamoxifen Tablets orally, twice a day, one tablet each time (10mg) and to be taken within 8 weeks from receiving ovarian function suppression treatment or after bilateral ovariectomy, and continue for 5 years or until endpoint event occurs. If the patients are not treated for 5 years because of adverse events (AE) or other reasons, the patient should be followed up until 5 years.

The treatment regimen of ovarian function suppression/ablation is as follows: Gonadotropin-releasing hormone analogue Goserelin Injection 3.6mg or Leuprorelin Injection 3.75 mg, a subcutaneous injection will be done every 28±2 days, or bilateral ovariectomy.

According to clinical practice of adjuvant endocrine therapy for Chinese patients with breast cancer, safety and effectiveness of all patients will be evaluated once every 3 months within 2 years after receiving the study treatment, every 6 months in 3 and 4 years, every 12 months in 5 years and 30 days after treatment discontinuation. After randomization, all patients should be regularly checked for signs, symptoms, and evidence of disease recurrence by collecting their medical history, physical examination, and local examination of the breast (specialized physical examination and/or imaging examination). Patients are advised to take a bone mineral density test once a year within five years from 6 months after randomization, and receive calcium or phosphate correspondingly based on the condition. Throughout the study, the adverse events need to be closely monitored, and the frequency and severity of adverse events are recorded as well.

The study results will be statistically analyzed after the study to compare the efficacy and safety variables between the two groups, thus, the superiority of Exemestane Tablets combined with ovarian function suppression/ablation to Tamoxifen Tablets combined with ovarian function suppression/ablation in disease-free survival (DFS) will be demonstrated. Stratified analyses according to lymph-node status and age.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized, open-label, parallel, active-controlled superiority clinical study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE CYP2D6 Polymorphism
Intervention  ICMJE
  • Drug: Exemestane Tablets
    drug therapy
  • Other: ovarian function suppression/ablation
    Gonadotropin-releasing hormone analogue Goserelin Injection 3.6mg or Leuprorelin Injection 3.75 mg, a subcutaneous injection should be done every 28±2 days; or Bilateral ovariectomy.
  • Genetic: CYP2D6*10 gene test
    CYP2D6*10 gene test
  • Drug: Tamoxifen
    drug therapy
Study Arms  ICMJE
  • Experimental: treatment group
    Exemestane Tablets combined with ovarian function suppression/ablation
    Interventions:
    • Drug: Exemestane Tablets
    • Other: ovarian function suppression/ablation
    • Genetic: CYP2D6*10 gene test
  • Active Comparator: control group
    Tamoxifen Tablets combined with ovarian function suppression/ablation
    Interventions:
    • Other: ovarian function suppression/ablation
    • Genetic: CYP2D6*10 gene test
    • Drug: Tamoxifen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 1, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2023
Estimated Primary Completion Date October 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Providing informed consent forms voluntarily before screening evaluation;
  • For Chinese premenopausal women, her estradiol level must be within the premenopausal level, or the patient meet the following 4 criteria in the prior 6 months: No chemotherapy, Regular menstruation, No use of hormonal, contraceptives, No use of hormone for treatment or for temporary amenorrhea caused by chemotherapy, the estradiol level tested within 8 months after the last dose of chemotherapeutics is within the premenopausal level;
  • Patients with invasive breast cancer which has been confirmed by histological examination;
  • Complete removal of tumor by surgery without local residual;
  • Neoadjuvant chemotherapy before surgery is permitted if the surgery for primary breast cancer is performed within 12 weeks without any further adjuvant chemotherapy, or adjuvant chemotherapy is completed within 8 months;
  • Estrogen receptor (ER) and/or progesterone receptor (PR) positive: If the patient has more than one breast tumor lesions, each tumor lesion should be ER and/or PR positive.
  • Her-2 negative;
  • Genotyping test performed by the central laboratory designated by sponsor with the results confirmed as CYP2D6*10T/T gene mutation.
  • Women of childbearing age with negative serum pregnancy test result, and agreeing to adopt highly efficient non-hormonal contraception measure throughout the study;
  • Subject without major organ dysfunction, and with normal heart, liver, kidney, lung and other major organ function.

Exclusion Criteria:

  • Inflammatory breast cancer;
  • Breast cancer patients with supraclavicular lymph nodes metastasis;
  • Patients with enlarged internal mammary lymph nodes (except for patients with negative pathologic findings);
  • Ovariectomy which is not specified in the study;
  • Patients with ovary protection during the chemotherapy;
  • Concomitant use of other aromatase inhibitors (not Exemestane);
  • Received major surgery which was unrelated to breast cancer within four weeks before randomization, or the patients had not yet fully recovered from such surgery;
  • Pregnant or lactating women;
  • Known active hepatitis B or hepatitis C or HIV;
  • Having difficulty in swallowing oral preparations and gastrointestinal dysfunction;
  • Recently had severe and uncontrolled systemic diseases (e.g.: cardiovascular disease, lung disease, or metabolic disease, venous thrombosis with clinical significance);
  • Currently or previously suffering from other malignant tumors (except for skin basal cell carcinoma or squamous cell carcinoma, carcinoma in situ of cervix which had been fully treated), unless a radical treatment had been done with the evidence of no-recurrence or metastasis in nearly five years;
  • Allergic to any study drug or any ingredients of drug;
  • Patient with poor compliance or other conditions which makes the patient unsuitable to participate in this study judged by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03137368
Other Study ID Numbers  ICMJE CH-BC-059
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Ma Fei, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP