Breast CancerPhase 3NCT00403182
Chemotherapy and Hormone Therapy as First-Line Therapy in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer
A Phase 3 study testing chemotherapy and letrozole in people with Breast Cancer, run by Technical University of Munich at 9 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 74 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- chemotherapy and letrozole
- How many people
- 0 participants
- Where
- 9 sitesGermany
- Study dates
- May 2006to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 74 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Kreiskrankenhaus
Ebersberg, D-85560
Gynaekologische Gemeinschaftspraxis - Pause, Thiel & Neuhofer
Freising, D-85354
Frauenklinik Universitaet Giessen
Giessen, D-35392
Klinikum Ingolstadt
Ingolstadt, 85049
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck, D-23538
Munich Oncologic Practice at Elisenhof
Munich, D-80335
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, D-81675
Praxis Kowolik Prechtl-Sattler
Munich, D-81925
Abt. Innere Medizin Onkologic
Schwarzenberg, 08340
About this study
Official title: The CORE Study (Chemotherapy OR Endocrine Treatment First?) A Randomized Study by the Scandinavian Breast Group [CORE]
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.
Read the detailed description
OBJECTIVES:
- 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 arms.
- 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.
- Conditions
- Breast Cancer
- Being tested
- chemotherapy, letrozole
- Keywords
- recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapyDrug
letrozoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Secondary outcomes (4)
Response to first and second treatment modalities as assessed by RECIST criteria
Time to first and second progression
Toxicity and safety as assessed by NCI CTCAE v3.0
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startMay 2006
Why it stopped: study halted prematurely, prior to enrollment of first participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Paepke, MD, Study chair, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403182
- Sponsor's protocol ID
- CDR0000515936
- Other IDs
- KRDI-TUM-CORE-GYN-040-380-2126, EU-20660, EUDRACT-2005-000986-20, KRDI-TUM-COR-259-PAE-0100-I
- Status last verified
- May 2012
- First submitted
- 21 Nov 2006
- Last updated
- 1 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CORE Study (Chemotherapy OR Endocrine Treatment First?) A Randomized Study by the Scandinavian Breast Group [CORE]
- ClinicalTrials.gov ID
- NCT00403182
- Acronym / sponsor ID
- CDR0000515936
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study halted prematurely, prior to enrollment of first participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- May 2006
- First posted
- 23 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- 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 arms.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chemotherapy | Drug | – |
| letrozole | Drug | – |
Primary outcome
Overall survival
4 secondary outcomes
Response to first and second treatment modalities as assessed by RECIST criteria
Time to first and second progression
Toxicity and safety as assessed by NCI CTCAE v3.0
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Paepke, MD study chair
Technical University of Munich
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing chemotherapy and letrozole in people with Breast Cancer, run by Technical University of Munich at 9 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2012.