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The CORE Study (Chemotherapy OR Endocrine Treatment First?) A Randomized Study by the Scandinavian Breast Group [CORE]

Phase 3
74 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

The CORE Study (Chemotherapy OR Endocrine Treatment First?) A Randomized Study by the Scandinavian Breast Group [CORE]


- Determine the optimal sequence of chemotherapy and endocrine therapy as first-line
therapy in postmenopausal women with metastatic or locally advanced breast cancer that
is potentially sensitive to both modalities.

OUTLINE: This is an open-label, randomized, crossover, multicenter study. Patients are
stratified according to participating center. Patients are randomized to 1 of 2 treatment

- Arm I (chemotherapy first): Beginning within 4 weeks after randomization, patients
receive chemotherapy* comprising either an anthracycline- or a taxane-based regimen, or
a combination of both drugs, according to local institutional guidelines. Treatment
continues for 6 months or longer, in the absence of disease progression or unacceptable
toxicity. After discontinuation of chemotherapy, patients receive endocrine therapy
comprising oral letrozole once daily in the absence of disease progression or
unacceptable toxicity. Patients with immediately life-threatening disease (e.g.,
lymphangitis carcinomatosa or liver involvement exceeding 1/3 of the liver) are
recommended for second-line chemotherapy.

NOTE: *Patients may receive chemotherapy on a separate clinical chemotherapy trial but must
first undergo randomization in this study.

- Arm II (endocrine therapy first):Beginning immediately after randomization, patients
receive oral letrozole once daily in the absence of disease progression or unacceptable
toxicity. Patients who demonstrate progressive disease then receive chemotherapy as in
arm I.

Quality of life and pain are assessed at baseline and then periodically for 5 years.

After completion of study therapy, patients are followed periodically.

PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed breast cancer

- Metastatic or locally advanced disease

- Bilateral breast cancer allowed

- Measurable or evaluable progressing metastases or local disease

- No sclerotic bone metastases as only disease

- Measurable or evaluable disease not in a previously irradiated area

- No immediately life-threatening metastatic disease

- No known HER2/neu positivity, as defined by either of the following:

- 3+ by immunohistochemistry

- HER2-positive by fluorescent in situ hybridization or chromogenic in situ

- No known cerebral or leptomeningeal metastases

- Hormone receptor status:

- Estrogen and/or progesterone receptor positive tumor


- Female

- Postmenopausal, as defined by any of the following:

- Bilateral oophorectomy and amenorrhea > 3 months

- Radiation castration and amenorrhea > 3 months

- Spontaneous menopause and amenorrhea > 12 months

- Previous hysterectomy and age > 55 years

- ECOG performance status 0-2

- Must be ambulant with organ function and performance status adequate for
conventional combination chemotherapy

- No serious hypersensitivity to letrozole or other components of study drug

- No other prior or concurrent malignancy except for basal cell carcinoma or carcinoma
in situ of the cervix


- No prior systemic treatment for recurrent or metastatic breast cancer

- No other concurrent radiotherapy, endocrine therapy, cytotoxic therapy, or
experimental therapy for cancer

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:


Principal Investigator

Stefan Paepke, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Technische Universit√§t M√ľnchen


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

May 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms