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Simultaneous Versus Sequential Use of Adjuvant Chemotherapy and GnRHa in Treating ER+,Premenopausal Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Zhimin Shao, Fudan University
ClinicalTrials.gov Identifier:
NCT01712893
First received: October 21, 2012
Last updated: October 23, 2012
Last verified: October 2012
History of Changes
  Purpose
The present study is a randomized open-label -phase III study that aims to compare the efficacy and safety of the adjuvant chemotherapy with simultaneous or sequential application of Zoladex up to 2-3 years for ≤ 45 year old premenopausal hormone receptor-positive breast cancer.

Condition Intervention Phase
Breast Cancer
 Drug: Zoladex
Drug: chemotherapy (Anthrocyclin combined with or followed by Taxanes)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III,Randomized,Open Label Study Comparing Simultaneous Versus Sequential Use of Adjuvant Chemotherapy and GnRHa up to 2-3 Years for ≤ 45 Year Old Pre-menopausal Hormone Receptor-positive Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Resumption of menstruation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    the Resumption that patients recover the natural menstrual or serum E2, FSH, LH return to the premenopausal range within 1 year after stopping Zoladex


Secondary Outcome Measures:
  • RFS [ Time Frame: 5years ] [ Designated as safety issue: No ]
    Relapse free survival (RFS): RFS related events ware defined as local-regional recurrence, distant metastasis or death, whichever occurred first.during follow up

  • OS [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Overall survival

  • Other adverse events [ Time Frame: 5years ] [ Designated as safety issue: Yes ]
    Other adverse events (Gynecological events, blood lipids, thrombosis, cardiovascular diseases, and etc.)
Estimated Enrollment: 220
Study Start Date: June 2009
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoladex combined with chemotherapy
After signing informed consent, patients will be screened, eligible patients were randomly divided into 2 groups, the test group should use Zoladex 3.6mg once a month up to 2-3 years combined with chemotherapy,all patients will receive Tamoxifen after chemotherapy
 Drug: Zoladex
Eligible patients were randomly divided into 2 groups, the intervention group should use Zoladex 3.6mg once a month up to 2-3 years combined with chemotherapy,and the control group should use chemotherapy alone followed by Zoladex
Other Name: Zoladex = GnRHa,Goserelin
Drug: chemotherapy (Anthrocyclin combined with or followed by Taxanes)
After signing informed consent, patients will be screened, eligible patients were randomly divided into 2 groups, the control group should Switch to use Zoladex 3.6mg once a month after chemotherapy up to 2-3 years,all patients will receive Tamoxifen after chemotherapy
Other Name: Anthrocyclin combined with or followed by Taxanes
Active Comparator: Zoladex after chemotherapy
After signing informed consent, patients will be screened, eligible patients were randomly divided into 2 groups, the control group should use Zoladex 3.6mg once a month up to 2-3 years after chemotherapy,all patients will receive Tamoxifen after chemotherapy
 Drug: Zoladex
Eligible patients were randomly divided into 2 groups, the intervention group should use Zoladex 3.6mg once a month up to 2-3 years combined with chemotherapy,and the control group should use chemotherapy alone followed by Zoladex
Other Name: Zoladex = GnRHa,Goserelin
Drug: chemotherapy (Anthrocyclin combined with or followed by Taxanes)
After signing informed consent, patients will be screened, eligible patients were randomly divided into 2 groups, the control group should Switch to use Zoladex 3.6mg once a month after chemotherapy up to 2-3 years,all patients will receive Tamoxifen after chemotherapy
Other Name: Anthrocyclin combined with or followed by Taxanes

Detailed Description:
Data showed that ovarian suppression therapy may protect the ovarian function in premenopausal patients received chemotherapy for breast cancer. However this is still a controversial issue. Sequential use of GnRHa (Zoladex) as ovarian suppression treatment after chemotherapy has been established as an effective endocrine therapy for ER positive premenopausal breast cancer. The present study is a randomized open-label phase III study that aims to observe the efficacy and safety of the adjuvant chemotherapy with simultaneous combination of Zoladex up to 2-3years and chemotherapy compared with the sequential schedule in ≤ 45 year old premenopausal hormone receptor-positive breast cancer patients.
  Eligibility
Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. female
  2. Primary invasive breast cancer pathologically approved by core needle or open biopsy

  3. Patients must have undergone standard surgery for primary breast cancer as shown in the following:

    • mastectomy
    • breast conservation surgery followed by whole breast radiation
    • axillary dissection or sentinel node biopsy
  4. Need adjuvant chemotherapy after surgery
  5. Patients taking neo-chemotherapy are eligible
  6. Patients with synchronous bilateral cancers are eligible on the condition that If one side is IDC and the other side is DCIS, the IDC side should be of the ER and/or PR positive phenotype and IF two sides are both IDC, they must be ER and/or PR positive phenotype at the same time
  7. Hormone receptor positive (≥＋) is defined as detecting ER or PR expression at any time is eligible. The situation of only PR positive and ER negative is eligible, too

  8. Based on the study objective, all patients are required to be premenopausal as defined by

    • menstruating actively
    • less than 6 months since last menstrual period (LMP), or patients younger than 40 years of age who became amenorrheic not more than 1 year if the serum free E2、FSH and LH level was premenopausal (according to the reference value of local center).
    • had previous hysterectomy with one or both ovaries left intact are eligible if the serum free E2、FSH and LH level are premenopausal (according to the reference value of local center).
  9. patients must have an ECOG performance status of 0 or 1 (0-fully active, able to carry on all pre-disease performance without restriction, 1-restricted in physical strenuous actively but ambulatory)
  10. leucocyte count must be ≥ 3.0*10^9/L and platelet count must be ≥ 100*10^9/L
  11. AST/SGOT or ALT/AGPT must be < 3 times the ULN
  12. serum creatinine must be < 2 times the ULN
  13. pregnancy testing is negative and are willing to do contraception during the treatment period

Exclusion Criteria:

  1. patients with metastatic malignant tumor
  2. previous history of asynchronous bilateral breast cancer
  3. any previous malignancy in the past 5 years, except for those treated with curative intent, such as carcinoma in situ of the cervix, squamous carcinoma of the skin or basal cell carcinoma of the skin
  4. any non-malignant systemic disease which interfere long time follow up
  5. history of medical ovarian ablation therapy
  6. severe live dysfunction, Child－Pugh is grade C
  7. Severe renal dysfunction
  8. Occult breast cancer
  9. severe heart dysfunction, heart functional classification is above Class III
  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: NCT01712893

Contacts
Contact: Zhi-Min Shao, MD 86-021-64175590 ext 8808 ext 8808 zhimingshao@yahoo.com
Contact: Guang-Yu Liu, MD 86-021-64175590 ext 8808 liugy123@yahoo.com

Locations
China, Shanghai
FUSCC Recruiting
Shanghai, Shanghai, China, 200032
Contact: guang-yu Liu, MD    86-021-64175590 ext 8808    liugy123@yahoo.com   
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Zhi-Min Shao, MD Fudan University
  More Information

Responsible Party: Zhimin Shao, Director of Department of Surgical Oncology,Cancer Hospital & Institute, Fudan University
ClinicalTrials.gov Identifier: NCT01712893     History of Changes
Other Study ID Numbers: CD trial 
Study First Received: October 21, 2012
Last Updated: October 23, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
breast cancer
adjuvant therapy
Ovarian suppression

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Goserelin
Taxane
Estrogen Antagonists
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 23, 2016