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A Randomized ,Open Label Study Comparing the Efficacy of Zoladex® Combined With Arimidex® for 3-2 Years After Selective Estrogen Receptor Modulators (SERMs) as an Adjuvant Therapy for 2-3 Years Versus Continuing Tamoxifen up to 5 Years for Premenopausal Early Breast Cancer Patients With Hormone Receptor Positive, Lymph Node Positive or Tumor≥ 4cm.


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Randomized ,Open Label Study Comparing the Efficacy of Zoladex® Combined With Arimidex® for 3-2 Years After Selective Estrogen Receptor Modulators (SERMs) as an Adjuvant Therapy for 2-3 Years Versus Continuing Tamoxifen up to 5 Years for Premenopausal Early Breast Cancer Patients With Hormone Receptor Positive, Lymph Node Positive or Tumor≥ 4cm.


Inclusion Criteria:



1. All patients must have signed and dated an informed consent form

2. Patients must be female

3. Primary invasive breast cancer pathologically approved by core needle or open biopsy

4. 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

5. 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

6. adjuvant endocrine therapy of TAM or Fareston must be started within 6 weeks when
adjuvant chemotherapy or radiotherapy was finished

7. 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

8. 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

9. Patients diagnosed as occult breast cancer clinically are found to pathologically
have primary invasive carcinoma or DCIS with micro-invasive lesion in ipsilateral
breast, and primary lesion or axillary node metastasis express ER and/or PR positive

10. 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

11. 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

12. According to the standard operation principles for clinical practice of local cancer
center, patients must be randomized within 4 weeks after definitive physical
examination, imaging examination and laboratory testing show no evidence of
recurrence or metastasis

13. 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).

14. 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)

15. leucocyte count must be ≥3.0*10^9/L and platelet count must be ≥100*10^9/L

16. AST/SGOT or ALT/AGPT must be <3 times the ULN

17. serum creatinine must be <2 times the ULN

18. patients can swallow pills

19. 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. history of AI therapy

7. severe live dysfunction, Child-Pugh is grade C

8. Occult breast cancer is found pathologically no IDC lesion or only DCIS without
micro-invasive lesion in the ipsilateral breast

9. patients with Her-2 overexpression had used, or is using, or intending to use
adjuvant trastuzumab

10. severe heart dysfunction, heart functional classification is above Class III Table 2
Child-Pugh score of hepatic cirrhosis

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

DFS

Outcome Description:

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

Outcome Time Frame:

5 Years

Safety Issue:

No

Authority:

China: Food and Drug Administration

Study ID:

CBCSG002

NCT ID:

NCT01352091

Start Date:

May 2008

Completion Date:

April 2018

Related Keywords:

  • Breast Cancer
  • breast cancer
  • adjuvant endocrine therapy
  • AI
  • Zoladex
  • Breast Neoplasms

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