Breast CancerPhase 3NCT00028704
Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy
A Phase 3 study testing conventional surgery and radiation therapy in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 13 sites in 7 countries.
Trial summary
RATIONALE: Breast-conserving treatments such as radiation therapy or limited surgery are less invasive than mastectomy and may improve the quality of life. It is not yet known if breast-conserving treatments are as effective as mastectomy followed by radiation therapy in treating locally advanced breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- conventional surgery and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 13 sitesin 7 countries
- Study dates
- Oct 2001to Dec 2003
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed locally advanced breast cancer
- T3 inoperable, N0-N2
- Any T, N2
- T4, N0-N2
- Inflammatory breast carcinoma
- Prior treatment with 4-6 courses of standard induction chemotherapy or active investigational regimens completed within the past 4 weeks
- Residual tumor size less than 5 cm
- No fixed axillary lymph nodes
- No multifocal or bilateral breast cancer
- No clinical suspicion of extensive ductal carcinoma in situ
- No unresolved skin edema
- No distant metastases (including ipsilateral supraclavicular node)
- Positive bone scan allowed provided there are no bone metastases on x-ray
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Any age
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- WHO 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 times normal
- SGOT and SGPT no greater than 2 times normal
- Alkaline phosphatase no greater than 2 times normal
Renal:
- Creatinine less than 1.5 times normal
Other:
- No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or adequately treated cone-biopsied carcinoma in situ of the cervix
- No serious underlying medical illness that would preclude study
- No psychiatric or addictive disorder that would preclude study
- No contraindication to study treatment
- Not pregnant
- Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- No concurrent hormonal replacement therapy
- No concurrent oral contraceptives
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy for breast cancer
Surgery:
- No prior surgery for breast cancer other than biopsy for diagnosis confirmation
Other:
- No other prior systemic therapy for breast cancer
Trial locations and contacts
13 sites in 7 countries.
13 sites in 7 countries
Netherlands4 sites
Akademisch Medisch Centrum
Amsterdam, 1105 AZ
Arnhems Radiotherapeutisch Instituut
Arnhem, 6815 AD
Leiden University Medical Center
Leiden, 2300 CA
Dr. Bernard Verbeeten Instituut
Tilburg, 5042 SB
Poland3 sites
Medical University of Gdansk
Gdansk, 80-211
Karol Marcinkowski University
Poznan, 60-355
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, 02-781
Belgium2 sites
Centre Hospitalier Etterbeek Ixelles
Brussels, B-1050
U.Z. Gasthuisberg
Leuven, B-3000
About this study
Official title: Conservative Local Treatment Versus Mastectomy After Induction Chemotherapy In Locally Advanced Breast Cancer: A Randomized Phase III Study
RATIONALE: Breast-conserving treatments such as radiation therapy or limited surgery are less invasive than mastectomy and may improve the quality of life. It is not yet known if breast-conserving treatments are as effective as mastectomy followed by radiation therapy in treating locally advanced breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of breast-conserving therapy with mastectomy followed by radiation therapy in treating women who have locally advanced breast cancer that has been previously treated with chemotherapy.
Read the detailed description
OBJECTIVES:
- Compare the overall survival and time to loco-regional failure in women with locally advanced breast cancer treated with breast-conserving local therapy vs mastectomy followed by radiotherapy after they have received prior induction chemotherapy.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, initial stage (T0, T1, T2, T3, or Tx vs T4), response to prior induction chemotherapy (complete response (CR) vs other), and menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo mastectomy followed by radiotherapy.
- Arm II: Patients receive breast-conserving treatment comprising 1 of 3 of the following therapeutic options:
- Regimen A: Patients receive radiotherapy alone.
- Regimen B: Patients with a partial response (PR) to prior induction chemotherapy undergo limited surgery followed by radiotherapy. Patients with a CR to prior induction chemotherapy undergo radiotherapy alone.
- Regimen C: Patients with a partial response (PR) or CR to prior induction chemotherapy undergo radiotherapy alone.
Patients with a CR to radiotherapy receive no further treatment. Patients with a PR to radiotherapy undergo limited surgery.
Quality of life is assessed at baseline, at the end of therapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Patients are followed within 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,300 patients (650 per treatment arm) will be accrued for this study within 5 years.
- Conditions
- Breast Cancer
- Being tested
- conventional surgery, radiation therapy
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, inflammatory breast cancer
- Medical subject headings
- Breast Neoplasms, Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional surgeryProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 2001
- Primary completionDec 2003
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- Central and Eastern European Oncology Group, Grupo Oncologico Cooperativo Chileno de Investigation, International Collaborative Cancer Group
- Responsible party
- Sponsor
- Investigators
- Jacek Jassem, MD, PhD, Study chair, Medical University of GdanskG. van Tienhoven, MD, PhD, Study chair, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Marzena Welnicka-Jaskiewicz, MD, Study chair, Medical University of GdanskRodrigo Arriagada, MD, Study chair, Instituto de RadiomedicinaMarie Emson, BSc, Study chair, International Collaborative Cancer Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028704
- Sponsor's protocol ID
- EORTC-10974-22002
- Other IDs
- EORTC-10974, CEEOG-EORTC-10974, EORTC-22002, GOCCHI-EORTC-10974, ICCG-EORTC-10974, EORTC-BIG-0002, LAMANOMA
- Status last verified
- Jul 2012
- First submitted
- 4 Jan 2002
- Last updated
- 18 Jul 2012
- Results posted
- No
Publications
Sinacki M, Jassem J, van Tienhoven G. Conservative local treatment versus mastectomy after induction chemotherapy in locally advanced breast cancer: a randomised phase III study (EORTC 10974/22002, LAMANOMA)--why did this study fail? Eur J Cancer. 2005 Dec;41(18):2787-8. doi: 10.1016/j.ejca.2005.06.027. Epub 2005 Nov 7. No abstract available.
PubMed 16274985
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Local Treatment Versus Mastectomy After Induction Chemotherapy In Locally Advanced Breast Cancer: A Randomized Phase III Study
- ClinicalTrials.gov ID
- NCT00028704
- Acronym / sponsor ID
- EORTC-10974-22002
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, inflammatory breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 26 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Collaborators
- Central and Eastern European Oncology Group, Grupo Oncologico Cooperativo Chileno de Investigation, International Collaborative Cancer Group
- Study start
- Oct 2001
- Primary completion
- Dec 2003 (actual)
- First posted
- 27 Jan 2003 (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: Breast-conserving treatments such as radiation therapy or limited surgery are less invasive than mastectomy and may improve the quality of life. It is not yet known if breast-conserving treatments are as effective as mastectomy followed by radiation therapy in treating locally advanced breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of breast-conserving therapy with mastectomy followed by radiation therapy in treating women who have locally advanced breast cancer that has been previously treated with chemotherapy.
Detailed description
OBJECTIVES:
- Compare the overall survival and time to loco-regional failure in women with locally advanced breast cancer treated with breast-conserving local therapy vs mastectomy followed by radiotherapy after they have received prior induction chemotherapy.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, initial stage (T0, T1, T2, T3, or Tx vs T4), response to prior induction chemotherapy (complete response (CR) vs other), and menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo mastectomy followed by radiotherapy.
- Arm II: Patients receive breast-conserving treatment comprising 1 of 3 of the following therapeutic options:
- Regimen A: Patients receive radiotherapy alone.
- Regimen B: Patients with a partial response (PR) to prior induction chemotherapy undergo limited surgery followed by radiotherapy. Patients with a CR to prior induction chemotherapy undergo radiotherapy alone.
- Regimen C: Patients with a partial response (PR) or CR to prior induction chemotherapy undergo radiotherapy alone.
Patients with a CR to radiotherapy receive no further treatment. Patients with a PR to radiotherapy undergo limited surgery.
Quality of life is assessed at baseline, at the end of therapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Patients are followed within 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,300 patients (650 per treatment arm) will be accrued for this study within 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- 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 |
|---|---|---|
| conventional surgery | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
- Results publication: PubMed 16274985Sinacki M, Jassem J, van Tienhoven G. Conservative local treatment versus mastectomy after induction chemotherapy in locally advanced breast cancer: a randomised phase III study (EORTC 10974/22002, LAMANOMA)--why did this study fail? Eur J Cancer. 2005 Dec;41(18):2787-8. doi: 10.1016/j.ejca.2005.06.027. Epub 2005 Nov 7. No abstract available.
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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.
Jacek Jassem, MD, PhD study chair
Medical University of Gdansk
G. van Tienhoven, MD, PhD study chair
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Marzena Welnicka-Jaskiewicz, MD study chair
Medical University of Gdansk
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing conventional surgery and radiation therapy in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 13 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands, Poland, Belgium, Chile, Israel and 2 more countries. 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: low accrual). 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00028704, which also lists 1 linked publication.
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 18 Jul 2012.