Adjuvant AI Combined With Zoladex

NCT01352091 | Unknown Phase 3 DMC

• 1 other identifier: CBCSG002
• Study Type: interventional
• Target: 670
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is a randomized open-label -phase III study that aims to compare the efficacy of Zoladex® combined with Aromidex® for 3-2 years after SERMs (tamoxifen and Fareston®) as an adjuvant therapy for 2-3 years with the efficacy of tamoxifen up to 5 years for premenopausal breast cancer women with hormone receptor positive, lymph node positive or tumor ≥4cm. According to St. Gallen's guideline, hormone receptor positive was defined as endocrine responsive and endocrine response uncertain categories (table 3-1), and only those with ER or PR expression undetectable were considered as HR negative. The pathological evaluation of axillary lymph node could be done by sentinel node biopsy (SNB) when axillary nodes were clinically impalpable accompanied with axillary lymph node dissection (ALND) or directly through ALND when axillary nodes appeared to be positive in clinical examination. Based on the operating standard of local medical institution, identifying the numbers of lymph nodes to do the pathological evaluation and to do the dissection of I- or II-station nodes accurately.

Conditions

Breast Cancer

Keywords

breast cancer; adjuvant endocrine therapy; AI; Zoladex

Outcome Measures

Primary Outcomes (1)

• DFS

  Disease free survival (DFS): DFS related events ware defined as local recurrence, distant metastasis, secondary primary cancer or death, whichever occurred first.during follow up

  5 Years

Secondary Outcomes (6)

• OS

  5 years

• Time to distant metastasis

  5 years

• Bilateral secondary primary breast cancer morbidity

  5 years

• DDFS

  5 years

• Osteoporosis related events

  5 years

Study Arms (2)

Switch to Zoladex + AI for 3-2 years

EXPERIMENTAL

Patients who took tamoxifen or Fareston for 2-3 years were randomized into 2 groups (335 patients for each group). One group would switch to receive Zoladex 3.6mg depot subcutaneously every month and Aromidex 1mg/d po for another 3-2 years

Drug: Zoladex+AI

TAM

EXPERIMENTAL

Patients who took tamoxifen or Fareston for 2-3 years were randomized into 2 groups (335 patients for each group). One group would receive TAM 20mg/d treated for 3-2 years.

Drug: TAM

Interventions

Zoladex+AI DRUG

Patients who took tamoxifen or Fareston for 2-3 years were randomized into 2 groups (335 patients for each group). One group would switch to receive Zoladex 3.6mg depot subcutaneously every month and Aromidex 1mg/d po for another 3-2 years

Switch to Zoladex + AI for 3-2 years

TAM DRUG

Patients who took tamoxifen or Fareston for 2-3 years were randomized into 2 groups (335 patients for each group). One group would receive TAM 20mg/d treated for 3-2 years.

TAM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must have signed and dated an informed consent form
• Patients must be female
• Primary invasive breast cancer pathologically approved by core needle or open biopsy
• Ipsilateral axillary or internal mammary nodes positive, or tumor size is equal to or larger than 4cm. Definition of nodes positive is according to the staging system of AJCC 6th edition (American Joint Cancer Commission) for breast carcinoma. The micrometastasis must be at least 0.2mm
• Patients must have undergone standard surgery for primary breast cancer as shown in the following:
• a standard radical mastectomy or modified mastectomy
• standard breast conservation surgery (BCS), which is lumpectomy or qaudrantectomy accompany with axillary dissection, and the surgical margins of the resected specimen must be negative. BCS must be followed by standardized adjuvant radiotherapy to the partial conserved breast (delivered after adjuvant chemotherapy completed)
• Treatment for confirmed breast cancer including the surgery modality listed above, loco-regional radiotherapy after lumpectomy, adjuvant radiotherapy to the chest wall and/or internal mammary nodes and/or supraclavicular lymph nodes, adjuvant chemotherapy
• adjuvant endocrine therapy of TAM or Fareston must be started within 6 weeks when adjuvant chemotherapy or radiotherapy was finished
• The date of randomization must be processed after taking TAM or Fareston for 2 or more than 2 years, but not more than 3 years of time
• Patients taking neo-chemotherapy are eligible, and lymph node status could be identified during surgery before neo-adjuvant chemotherapy or after neo-adjuvant chemotherapy. The definition of lymph node positive is:
• evaluation of lymph node status before neo-adjuvant chemotherapy must include pathological axillary nodes, internal mammary nodes (pN2b option) or supraclavicular nodes (pN3c option) involved. Micro-metastasis (i.e.≥0.2mm, pN1-pN3c) can be identified by the following method: fine needle aspiration (FNA) or sentinel node biopsy (SNB) or sampling/ total procedure of axillary dissection
• patients with no nodes positive after neo-adjuvant chemotherapy, lymph node positive must be evaluated during surgery. Its definition was the either of following:
• According the clinical practice guidelines of the local cancer center, it is acceptable when positive nodes was identified by SNB or axillary dissection
• There is pathological evidence in lymph nodes positive (pN1-pN3c) during breast surgery after neo-adjuvant chemotherapy

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
• history of AI therapy
• severe live dysfunction, Child-Pugh is grade C
• Occult breast cancer is found pathologically no IDC lesion or only DCIS without micro-invasive lesion in the ipsilateral breast
• patients with Her-2 overexpression had used, or is using, or intending to use adjuvant trastuzumab
• severe heart dysfunction, heart functional classification is above Class III Table 2 Child-Pugh score of hepatic cirrhosis

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

FUSCC

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• Li JW, Liu GY, Ji YJ, Yan X, Pang D, Jiang ZF, Chen DD, Zhang B, Xu BH, Shao ZM. Switching to anastrozole plus goserelin vs continued tamoxifen for adjuvant therapy of premenopausal early-stage breast cancer: preliminary results from a randomized trial. Cancer Manag Res. 2018 Dec 27;11:299-307. doi: 10.2147/CMAR.S183672. eCollection 2019.

  PMID: 30643455 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhi-min Shao, MD

CONTACT

86-021-64175590; zhimingshao@yahoo.com

Ya-jie Ji, MD

CONTACT

86-13818942254; jing_hong2008@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 10, 2011
• First Posted: May 11, 2011
• Study Start: May 1, 2008
• Primary Completion: May 1, 2015
• Study Completion: April 1, 2018
• Last Updated: May 11, 2011

Record last verified: 2008-04

Locations

CN (1)