Adjuvant Toremifene With or Without Goserrelin in Premenopausal Women With Stage I-IIIA, Hormonal Receptor Positive Breast Cancer Accompanied With or Without Chemotherapy Induced Amenorrhoea

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
ZHOU Yidong, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT02132390
First received: May 5, 2014
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

Compare the potential benefits of adjuvant toremifene with or without goserelin in premenopausal women with stage I-IIIA, hormonal receptor positive breast cancer accompanied with or without chemotherapy induced amenorrhoea.


Condition Intervention Phase
Breast Cancer
Chemotherapy Induced Amenorrhea
Ovarian Function Suppression
Drug: Goserelin
Drug: Toremifene
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Adjuvant Toremifene With or Without Goserrelin in Premenopausal Women With Stage I-IIIA, Hormonal Receptor Positive Breast Cancer Accompanied With or Without Chemotherapy Induced Amenorrhoea

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: up to 120 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: up to 120 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: up to 120 months ] [ Designated as safety issue: No ]
  • Bone mineral density loss [ Time Frame: up to 120 months ] [ Designated as safety issue: No ]
    measured by dual energy X-ray absorptiometry scans at every 12 months and by serum biomarkers

  • Hormone levels [ Time Frame: up to 120 months ] [ Designated as safety issue: No ]
  • Incidence of pregnancy [ Time Frame: up to 120 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2014
Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients who didn't have CIA receive oral toremifene daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity
Drug: Toremifene
Experimental: Arm II
Patients who had CIA receive toremifene as in arm I
Drug: Toremifene
Experimental: Arm III
Patients without CIA receive oral toremifene and goserelin for ovarian function suppression
Drug: Goserelin
Other Name: Zoladex
Experimental: Arm IV
Patients with CIA receive oral toremifene and goserelin for ovarian function suppression.
Drug: Goserelin
Other Name: Zoladex

Detailed Description:

This is a single center, randomized, controlled study. Patients undergo surgical resection with standard Doxorubicin/Cyclophosphamide Followed by Docetaxel (AC-T).

Chemotherapy begins within 4 weeks after surgery for patients randomized to arm I-IV. Arm I: patients who didn't have CIA receive oral toremifene daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity. Arm II: patients who had CIA receive toremifene as in arm I. Arm III: patients without CIA receive oral toremifene and goserelin for ovarian function suppression. Arm IV: patients with CIA receive oral toremifene and goserelin for ovarian function suppression. Patients are followed every 6 months for 5 years and annually thereafter.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures
  • Age of at least 18 and at most 45 years
  • Spontaneous and regular menstrual periods before study entry with FSH below 15 mlU/ml in follicular phase
  • Histologically confirmed primary breast cancer with the need for anthracycline-based chemotherapy
  • Steroid receptor (estrogen and progesterone) positive tumor (diagnosis according to hospital standard-procedures)
  • No clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated
  • Karnofsky-Index >80%
  • Life expectancy of at least 10 years, disregarding the diagnosis of cancer
  • Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution
  • Patients underwent standard Doxorubicin/Cyclophosphamide Followed by Docetaxel (AC-T)
  • Patients must be available for and compliant to treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating center.

Exclusion Criteria:

  • Known hypersensitivity reaction to the investigational compounds or incorporated substances
  • Prior cytotoxic treatment for any reason
  • Suspected (primary or secondary) ovarian insufficiency
  • Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration and must implement adequate non-hormonal contraceptive measures during study treatment; prior use of hormonal contraceptives has to be discontinued before first Goserelin injection
  • Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study
  • Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix)
  • Concurrent treatment with other experimental drugs or any other anti-cancer therapy
  • Concurrent treatment with sex hormones. Prior treatment must be stopped before study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02132390

Contacts
Contact: Yidong ZHOU, Master 0086-10-69152700 wcj_sumy@126.com
Contact: Changjun WANG, Doctor 0086-10-69152700

Locations
China, Beijing
Peking Union Medical College Hospital Not yet recruiting
Beijing, Beijing, China, 100730
Contact: Yidong ZHOU, Master    8610-69152700    wcj_sumy@126.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: ZHOU Yidong, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02132390     History of Changes
Other Study ID Numbers: PUMCH-Breast-CIA
Study First Received: May 5, 2014
Last Updated: June 2, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Peking Union Medical College Hospital:
Breast cancer
Chemotherapy induced amenorrhea
Goserelin

Additional relevant MeSH terms:
Amenorrhea
Breast Neoplasms
Menstruation Disturbances
Pathologic Processes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Toremifene
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 23, 2014