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

NCT01712893 | Completed Phase 3 DMC

• 1 other identifier: CD trial
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; adjuvant therapy; Ovarian suppression

Outcome Measures

Primary Outcomes (1)

• Resumption of menstruation

  the Resumption that patients recover the natural menstrual or serum E2, FSH, LH return to the premenopausal range within 1 year after stopping Zoladex

  1 year

Secondary Outcomes (3)

• RFS

  5years

• OS

  5 years

• Other adverse events

  5years

Study Arms (2)

Zoladex combined with chemotherapy

EXPERIMENTAL

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

Zoladex after chemotherapy

ACTIVE COMPARATOR

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

Interventions

Zoladex DRUG

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

Also known as: Zoladex = GnRHa,Goserelin

Zoladex after chemotherapy; Zoladex combined with chemotherapy

Eligibility Criteria

• Age: Up to 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

FUSCC

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Goserelin

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

Study Officials

• Zhi-Min Shao, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Surgical Oncology,Cancer Hospital & Institute

Study Record Dates

• First Submitted: October 21, 2012
• First Posted: October 24, 2012
• Study Start: June 1, 2009
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 25, 2017

Record last verified: 2017-08

Locations

CN (1)