Clinical trial · Interventional
Chemotherapy and Hormone Therapy as First-Line Therapy in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer
The CORE Study (Chemotherapy OR Endocrine Treatment First?) A Randomized Study by the Scandinavian Breast Group [CORE]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): study halted prematurely, prior to enrollment of first participant
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether giving chemotherapy before hormone therapy is more effective than giving hormone therapy before chemotherapy in treating breast cancer. PURPOSE: This randomized phase III trial is studying chemotherapy to see how well it works when given before or after hormone therapy as first-line therapy in treating postmenopausal women with metastatic or locally advanced breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Drug | Chemotherapy | ALIAS |
| letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
Secondary outcomes (4)
- measure
- Response to first and second treatment modalities as assessed by RECIST criteria
- measure
- Time to first and second progression
- measure
- Toxicity and safety as assessed by NCI CTCAE v3.0
- measure
- Quality of life as assessed by Hospital Anxiety and Depression Scale (HADS-D), Functional Assessment of Cancer Therapy-General (FACT-G), FBK-R23, and FLZ-G periodically for 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 74 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * 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 hybridization * No known cerebral or leptomeningeal metastases * Hormone receptor status: * Estrogen and/or progesterone receptor positive tumor PATIENT CHARACTERISTICS: * 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 PRIOR CONCURRENT THERAPY: * No prior systemic treatment for recurrent or metastatic breast cancer * No other concurrent radiotherapy, endocrine therapy, cytotoxic therapy, or experimental therapy for cancer
References
Publications (0)
Data not yet available