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

NCT02132390 | Unknown Phase 3 DMC

• 1 other identifier: PUMCH-Breast-CIA
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Chemotherapy Induced Amenorrhea; Ovarian Function Suppression

Keywords

Breast cancer; Chemotherapy induced amenorrhea; Goserelin

Outcome Measures

Primary Outcomes (2)

• Disease free survival

  up to 120 months

• Overall Survival

  up to 120 months

Secondary Outcomes (4)

• Quality of life

  up to 120 months

• Bone mineral density loss

  up to 120 months

• Hormone levels

  up to 120 months

• Incidence of pregnancy

  up to 120 months

Study Arms (4)

Arm I

EXPERIMENTAL

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

Arm II

EXPERIMENTAL

Patients who had CIA receive toremifene as in arm I

Drug: Toremifene

Arm III

EXPERIMENTAL

Patients without CIA receive oral toremifene and goserelin for ovarian function suppression

Drug: Goserelin

Arm IV

EXPERIMENTAL

Patients with CIA receive oral toremifene and goserelin for ovarian function suppression.

Drug: Goserelin

Interventions

Goserelin DRUG

Also known as: Zoladex

Arm III; Arm IV

Toremifene DRUG

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Goserelin; Toremifene

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Yidong ZHOU, Master

CONTACT

0086-10-69152700; wcj_sumy@126.com

Changjun WANG, Doctor

CONTACT

0086-10-69152700

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 7, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2024
• Last Updated: June 4, 2014

Record last verified: 2014-06

Locations

CN (1)