Operable Breast NeoplasmsPhase 3REALNCT00908531
Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer
A Phase 3 study testing letrozole (Femara) in people with Operable Breast Neoplasms, run by Danish Breast Cancer Cooperative Group at 9 sites in Denmark.
Trial summary
The hypothesis to be addressed in this randomized phase III trial is that 4 months of letrozole may be superior to surgery as primary therapy for early stage hormone receptor positive breast cancer in postmenopausal women, provided that these patients will receive definitive and radical surgery and adjuvant therapies… Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Operable Breast Neoplasms
- What is being tested?
- letrozole (Femara)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 9 sitesDenmark
- Study dates
- May 2009to 1 Dec 2013
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Age 60 years or older
- Measurable non-metastatic and non-inflammatory breast cancer
- Tumor of 2 cm or larger
- ER and/or PgR positive tumor
- Co-morbidity index 0 - 3, e.g., no other serious medical condition
Who cannot join
- Prior medical therapy for a malignant disease, including aromatase inhibitors
- Distant metastasis
- Need for chemotherapy
- Past or current history of other neoplasms (except for curative treated basal skin cancer or in situ carcinoma of the cervix uteri)
- Treatment with a non-approved drug within 30 days
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Denmark9 sites
Dept. of Breast Surgery; Aalborg Sygehus
Aalborg, DK-9000
Dept. of Surgery; Århus Sygehus
Aarhus, DK-8000
Dept. of Breast Surgery; Rigshospitalet
Copenhagen, DK-2100
Dept. of Surgery; Sydvestjysk Sygehus Esbjerg
Esbjerg, DK-6700
Dept. of Breast Surgery; Herlev Hospital
Herlev, DK-2730
Dept. of Oncology; Odense University Hospital
Odense, DK-5000
Depart. of Breast Surgery, Ringsted Sygehus
Ringsted, 4100
Dept. of Breast Surgery; Vejle Sygehus
Vejle, DK-7100
Dept. of Breast Surgery; Regionshospitalet Viborg
Viborg, DK-8800
About this study
Official title: Randomized Trial of Endocrine Therapy Against Locoregional Therapy First. A DBCG Trial in Postmenopausal Patients With Operable Hormone Receptor Positive Tumors Larger Than 2 cm.
The hypothesis to be addressed in this randomized phase III trial is that 4 months of letrozole may be superior to surgery as primary therapy for early stage hormone receptor positive breast cancer in postmenopausal women, provided that these patients will receive definitive and radical surgery and adjuvant therapies as otherwise indicated at the completion of preoperative letrozole.
- Conditions
- Operable Breast Neoplasms
- Being tested
- letrozole (Femara)
- Keywords
- Breast neoplasms, Randomised trial, Aromatase Inhibitors, Preoperative care, Age 60 or older, Hormone receptor positive tumor, Tumor lager than 2 cm, No distant metastasis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
letrozole (Femara)Drug
Also called Femara
tablet 2.5 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Postoperative letrozole | Active comparator | Definitive surgery without preoperative AI treatment Receives: Drug: letrozole (Femara) |
| Preoperative letrozole | Experimental | Treatment with letrozole for 4 months before definitive surgery. Receives: Drug: letrozole (Femara) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
Complete response rate
Measured: At four months
Clinical tumor response
Ultrasound
Measured: At four months
Secondary outcomes (1)
Overall survival
Death of any cause
Measured: At ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startMay 2009
- Primary completion1 Dec 2013
- Study completion1 Dec 2013
Why it stopped: Poor recruitement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Operable Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Breast Cancer Cooperative Group
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Medical Research Council, Danish Cancer Society, Novartis
- Responsible party
- Principal investigator, Bent Ejlertsen, Danish Breast Cancer Cooperative Group
- Investigators
- Bent Ejlertsen, MD, PhD, Principal investigator, DBCG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908531
- Sponsor's protocol ID
- DBCG 07-REAL
- Acronym
- REAL
- Status last verified
- Apr 2019
- First submitted
- 26 May 2009
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Skriver SK, Laenkholm AV, Rasmussen BB, Handler J, Grundtmann B, Tvedskov TF, Christiansen P, Knoop AS, Jensen MB, Ejlertsen B. Neoadjuvant letrozole for postmenopausal estrogen receptor-positive, HER2-negative breast cancer patients, a study from the Danish Breast Cancer Cooperative Group (DBCG). Acta Oncol. 2018 Jan;57(1):31-37. doi: 10.1080/0284186X.2017.1401228. Epub 2017 Nov 23.
PubMed 29168427Skriver SK, Jensen MB, Knoop AS, Ejlertsen B, Laenkholm AV. Tumour-infiltrating lymphocytes and response to neoadjuvant letrozole in patients with early oestrogen receptor-positive breast cancer: analysis from a nationwide phase II DBCG trial. Breast Cancer Res. 2020 May 14;22(1):46. doi: 10.1186/s13058-020-01285-8.
PubMed 32410705
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Endocrine Therapy Against Locoregional Therapy First. A DBCG Trial in Postmenopausal Patients With Operable Hormone Receptor Positive Tumors Larger Than 2 cm.
- ClinicalTrials.gov ID
- NCT00908531
- Acronym / sponsor ID
- REAL / DBCG 07-REAL
- Conditions
- Operable Breast Neoplasms
- Keywords
- Breast neoplasms, Randomised trial, Aromatase Inhibitors, Preoperative care, Age 60 or older, Hormone receptor positive tumor, Tumor lager than 2 cm, No distant metastasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitement
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Danish Breast Cancer Cooperative GroupUniversity, hospital or other
- Collaborators
- The Danish Medical Research Council, Danish Cancer Society, Novartis
- Study start
- May 2009
- Primary completion
- 1 Dec 2013 (actual)
- Study completion
- 1 Dec 2013 (actual)
- First posted
- 27 May 2009 (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.
The hypothesis to be addressed in this randomized phase III trial is that 4 months of letrozole may be superior to surgery as primary therapy for early stage hormone receptor positive breast cancer in postmenopausal women, provided that these patients will receive definitive and radical surgery and adjuvant therapies as otherwise indicated at the completion of preoperative letrozole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative letrozole | Active comparator | Drug: letrozole (Femara)Definitive surgery without preoperative AI treatment |
| Preoperative letrozole | Experimental | Drug: letrozole (Femara)Treatment with letrozole for 4 months before definitive surgery. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent
- Age 60 years or older
- Measurable non-metastatic and non-inflammatory breast cancer
- Tumor of 2 cm or larger
- ER and/or PgR positive tumor
Key exclusion criteria (5 listed)
- Prior medical therapy for a malignant disease, including aromatase inhibitors
- Distant metastasis
- Need for chemotherapy
- Past or current history of other neoplasms (except for curative treated basal skin cancer or in situ carcinoma of the cervix uteri)
- Treatment with a non-approved drug within 30 days
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 |
|---|---|---|
| letrozole (Femara)Also: Femaratablet 2.5 mg daily | Drug | Postoperative letrozole, Preoperative letrozole |
Primary outcome
pCR
Time frame: At four months
Complete response rate
Clinical tumor response
Time frame: At four months
Ultrasound
1 secondary outcome
Overall survival
Time frame: At ten years
Results and safety
The study was stopped early (reason given: Poor recruitement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Background: PubMed 29168427Skriver SK, Laenkholm AV, Rasmussen BB, Handler J, Grundtmann B, Tvedskov TF, Christiansen P, Knoop AS, Jensen MB, Ejlertsen B. Neoadjuvant letrozole for postmenopausal estrogen receptor-positive, HER2-negative breast cancer patients, a study from the Danish Breast Cancer Cooperative Group (DBCG). Acta Oncol. 2018 Jan;57(1):31-37. doi: 10.1080/0284186X.2017.1401228. Epub 2017 Nov 23.
- Derived from this study: PubMed 32410705Skriver SK, Jensen MB, Knoop AS, Ejlertsen B, Laenkholm AV. Tumour-infiltrating lymphocytes and response to neoadjuvant letrozole in patients with early oestrogen receptor-positive breast cancer: analysis from a nationwide phase II DBCG trial. Breast Cancer Res. 2020 May 14;22(1):46. doi: 10.1186/s13058-020-01285-8.
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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.
Bent Ejlertsen, MD, PhD principal investigator
DBCG
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 letrozole (Femara) in people with Operable Breast Neoplasms, run by Danish Breast Cancer Cooperative Group at 9 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. 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: stopped early, as of the sponsor's last update on 29 Apr 2019. 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 Denmark. 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 stopped early (reason given: Poor recruitement). Results are not available in the source record.
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?
pCR (time frame: At four months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00908531, which also lists 2 linked publications.
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 29 Apr 2019.