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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Zoladex	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	216 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	June 2009
Actual Primary Completion Date :	August 2017
Actual Study Completion Date :	August 2017

Arms and Interventions

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Arm	Intervention/treatment
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
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

Outcome Measures

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Primary Outcome Measures :

1. Resumption of menstruation [ Time Frame: 1 year ]
   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 :

1. RFS [ Time Frame: 5years ]
   Relapse free survival (RFS): RFS related events ware defined as local-regional recurrence, distant metastasis or death, whichever occurred first.during follow up
2. OS [ Time Frame: 5 years ]
   Overall survival
3. Other adverse events [ Time Frame: 5years ]
   Other adverse events (Gynecological events, blood lipids, thrombosis, cardiovascular diseases, and etc.)

Eligibility Criteria

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Ages Eligible for Study:	up to 45 Years (Child, Adult)
Sexes 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

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Locations

China, Shanghai
FUSCC
Shanghai, Shanghai, China, 200032

Sponsors and Collaborators

Fudan University

Investigators

Principal Investigator:	Zhi-Min Shao, MD	Fudan University

More Information

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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
First Posted:	October 24, 2012
Last Update Posted:	August 25, 2017
Last Verified:	August 2017

Keywords provided by Zhimin Shao, Fudan University:

breast cancer; adjuvant therapy; Ovarian suppression

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases	Skin Diseases; Goserelin; Antineoplastic Agents, Hormonal; Antineoplastic Agents