Simultaneous Versus Sequential Use of Adjuvant Chemotherapy and GnRHa in Treating ER+,Premenopausal Breast Cancer
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ClinicalTrials.gov Identifier: NCT01712893 |
Recruitment Status
:
Completed
First Posted
: October 24, 2012
Last Update Posted
: August 25, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: Zoladex | Phase 3 |
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 |

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
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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
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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
|
- 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
- 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
- OS [ Time Frame: 5 years ]Overall survival
- Other adverse events [ Time Frame: 5years ]Other adverse events (Gynecological events, blood lipids, thrombosis, cardiovascular diseases, and etc.)

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Ages Eligible for Study: | up to 45 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- female
- Primary invasive breast cancer pathologically approved by core needle or open biopsy
-
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
- Need adjuvant chemotherapy after surgery
- Patients taking neo-chemotherapy are eligible
- 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
- 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
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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).
- 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)
- leucocyte count must be ≥ 3.0*10^9/L and platelet count must be ≥ 100*10^9/L
- AST/SGOT or ALT/AGPT must be < 3 times the ULN
- serum creatinine must be < 2 times the ULN
- pregnancy testing is negative and are willing to do contraception during the treatment period
Exclusion Criteria:
- patients with metastatic malignant tumor
- previous history of asynchronous bilateral breast cancer
- 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
- any non-malignant systemic disease which interfere long time follow up
- history of medical ovarian ablation therapy
- severe live dysfunction, Child-Pugh is grade C
- Severe renal dysfunction
- Occult breast cancer
- severe heart dysfunction, heart functional classification is above Class III

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712893
China, Shanghai | |
FUSCC | |
Shanghai, Shanghai, China, 200032 |
Principal Investigator: | Zhi-Min Shao, MD | Fudan University |
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 Key Record Dates |
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 |