Breast CancerPhase 3NCT00005983
S9927 Radiation Therapy After Surgery, Chemotherapy, and/or Hormone Therapy in Stage II Breast Cancer
A Phase 3 study testing radiation therapy and surgery in people with Breast Cancer, run by SWOG Cancer Research Network at 1 site in Canada.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether mastectomy, chemotherapy, and/or hormone therapy are more effective with or without radiation therapy in treating breast cancer. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- radiation therapy and surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2000to Mar 2005
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed stage II adenocarcinoma of the breast (T1-2, N1, M0)
- Primary tumor no greater than 5 cm
- At least 1 but no more than 3 positive axillary lymph nodes
- Nodes cannot be positive solely by cytokeratin staining
- No apocrine, adenocystic, or squamous cell carcinomas or sarcomas of the breast
- No bilateral breast cancer
- No active local regional disease
- Must have undergone a modified radical mastectomy with a level I and II with or without a level III axillary dissection (at least 10 nodes examined) within the past 8 months
- Surgical margins negative for invasive and noninvasive ductal carcinoma
- No gross extracapsular disease or residual disease in the axilla
- Microscopic extracapsular extension allowed
- No mastectomy after local failure following lumpectomy
- Must have received adjuvant chemotherapy and/or hormonal therapy after mastectomy
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 21 and over
Sex:
- Female
Menopausal status:
- Pre- or post-menopausal
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No serious medical or psychiatric illness that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior trastuzumab (Herceptin)
Chemotherapy:
- See Disease Characteristics
- No more than 6 weeks since prior adjuvant chemotherapy
- No other prior chemotherapy
- Concurrent adjuvant chemotherapy allowed
Endocrine therapy:
- See Disease Characteristics
- Concurrent adjuvant hormonal therapy allowed
Radiotherapy:
- No prior chest wall or nodal radiotherapy
Surgery:
- See Disease Characteristics
- Breast reconstruction allowed
Other:
- Concurrent registration on another adjuvant chemotherapy or hormonal therapy study is allowed
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
About this study
Official title: Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes Phase III
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether mastectomy, chemotherapy, and/or hormone therapy are more effective with or without radiation therapy in treating breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of mastectomy, chemotherapy, and/or hormone therapy with or without radiation therapy in treating women who have stage II breast cancer.
Read the detailed description
OBJECTIVES:
- Compare overall and disease-free survival in women with stage II breast cancer with one to three positive nodes treated with radiotherapy vs observation only after mastectomy and adjuvant chemotherapy and/or hormonal therapy.
- Compare local regional control in patients treated with these regimens.
- Assess the potential toxic effects of radiotherapy in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior systemic hormonal therapy (chemotherapy with or without hormonal therapy vs hormonal therapy alone), prior taxane exposure (yes vs no), and duration of chemotherapy (no chemotherapy vs less than 3 months vs 3-5 months vs 6 months or more). Patients are randomized to one of two treatment arms.
- Arm I: Patients undergo radiotherapy 5 days a week for 5 weeks.
- Arm II: Patients are observed for disease progression. Patients are followed every 6 months for 2 years and then annually for 15 years.
PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per treatment arm) will be accrued for this study within 5 years.
- Conditions
- Breast Cancer
- Being tested
- radiation therapy, surgery
- Keywords
- stage II 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.
radiation therapyRadiation
surgeryProcedure or surgery
surgery
| Study group | Role | What they receive |
|---|---|---|
| surgery | Active comparator | surgery followed by observation Receives: Procedure: surgery |
| surgery followed by RT | Experimental | Surgery followed by radiation therapy Receives: Radiation: radiation therapy; Procedure: surgery |
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 startJun 2000
- Primary completionMar 2005
- Study completionMar 2005
Why it stopped: due to lack of accrual
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 SWOG Cancer Research NetworkThe 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), North Central Cancer Treatment Group, American College of Surgeons, Eastern Cooperative Oncology Group, Radiation Therapy Oncology Group, Cancer and Leukemia Group B, NCIC Clinical Trials Group, NSABP Foundation Inc
- Responsible party
- Sponsor
- Investigators
- Lori J. Pierce, MD, Study chair, University of Michigan Rogel Cancer CenterMichael G. Haddock, MD, Study chair, Mayo ClinicStephen B. Edge, MD, Study chair, Roswell Park Cancer InstituteEric A. Strom, MD, FACR, Study chair, M.D. Anderson Cancer CenterLawrence J. Solin, MD, FACR, Study chair, Abramson Cancer Center at Penn MedicineLawrence B. Marks, MD, Study chair, Duke UniversityTimothy J. Whelan, MD, Study chair, Margaret and Charles Juravinski Cancer CentreMelvin Deutsch, MD, Study chair, UPMC Cancer Center at UPMC Presbyterian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005983
- Sponsor's protocol ID
- CDR0000067971
- Other IDs
- U10CA032102, S9927, S9927, CAN-NCIC-MA25, CLB-49910, S9927, S9927, S9927
- Status last verified
- Jan 2013
- First submitted
- 5 Jul 2000
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes Phase III
- ClinicalTrials.gov ID
- NCT00005983
- Acronym / sponsor ID
- CDR0000067971
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to lack of accrual
- Enrolment
- 98 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI), North Central Cancer Treatment Group, American College of Surgeons, Eastern Cooperative Oncology Group, Radiation Therapy Oncology Group, Cancer and Leukemia Group B, NCIC Clinical Trials Group, NSABP Foundation Inc
- Study start
- Jun 2000
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (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: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether mastectomy, chemotherapy, and/or hormone therapy are more effective with or without radiation therapy in treating breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of mastectomy, chemotherapy, and/or hormone therapy with or without radiation therapy in treating women who have stage II breast cancer.
Detailed description
OBJECTIVES:
- Compare overall and disease-free survival in women with stage II breast cancer with one to three positive nodes treated with radiotherapy vs observation only after mastectomy and adjuvant chemotherapy and/or hormonal therapy.
- Compare local regional control in patients treated with these regimens.
- Assess the potential toxic effects of radiotherapy in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior systemic hormonal therapy (chemotherapy with or without hormonal therapy vs hormonal therapy alone), prior taxane exposure (yes vs no), and duration of chemotherapy (no chemotherapy vs less than 3 months vs 3-5 months vs 6 months or more). Patients are randomized to one of two treatment arms.
- Arm I: Patients undergo radiotherapy 5 days a week for 5 weeks.
- Arm II: Patients are observed for disease progression. Patients are followed every 6 months for 2 years and then annually for 15 years.
PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per treatment arm) will be accrued for this study within 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery | Active comparator | Procedure: surgerysurgery followed by observation |
| surgery followed by RT | Experimental | Radiation: radiation therapy, Procedure: surgerySurgery followed by radiation therapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| radiation therapy | Radiation | surgery followed by RT |
| surgerysurgery | Procedure or surgery | surgery, surgery followed by RT |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: due to lack of accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
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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.
Lori J. Pierce, MD study chair
University of Michigan Rogel Cancer Center
Michael G. Haddock, MD study chair
Mayo Clinic
Stephen B. Edge, MD study chair
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing radiation therapy and surgery in people with Breast Cancer, run by SWOG Cancer Research Network at 1 site in Canada.
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: stopped early, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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: due to lack of 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?
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 24 Jan 2013.