Female Breast NeoplasmsPhase 3NCT01508546
Conservative Surgery With or Without Axillary Lymphnode Removal in Treating Women With T1N0 Breast Cancer
A Phase 3 study testing axillary dissection in people with Female Breast Neoplasms and Carcinoma, Ductal, Breast, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
Rationale Axillary surgery is still fundamental part of breast cancer (BC) management for adjuvant treatment planning. Purpose Randomized phase III trial to compare the effectiveness of surgical therapy with or without axillary dissection following conservative treatment in women with stage I breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Female Breast Neoplasms, Carcinoma, Ductal, Breast
- What is being tested?
- axillary dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 565 participants
- Where
- 1 siteItaly
- Study dates
- May 1998to May 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women with T1N0M0 invasive breast cancer
- 18-65 years
Who cannot join
- bilateral breast cancer
- no other prior or concurrent malignancy except basal cell carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Rationale
Axillary surgery is still fundamental part of breast cancer (BC) management for adjuvant treatment planning.
Purpose
Randomized phase III trial to compare the effectiveness of surgical therapy with or without axillary dissection following conservative treatment in women with stage I breast cancer.
To determine the possibility to avoid axillary surgery in patients with early breast cancer, finding an alternative method to define the need of adjuvant treatment without compromising long-term disease control.
Read the detailed description
OBJECTIVES:
To compare the efficacy of conservative surgery, with or without axillary lymphnode removal (quadrantectomy with axillary dissection (QUAD) vs. quadrantectomy alone (QU)) followed by adjuvant treatment.
To plan no adjuvant therapy vs. adjuvant therapy (eA+CMF+TAM regimen) based on a biological panel of the primary tumor in the QU group (defined as good panel (GP) ( ER+, and up to one unfavourable features (G3, Her2+++, Laminin Receptor+) or bad panel (BP)(ER-, or ER+ and more than one unfavourable features), whereas in QUAD group based on good factor ( N-, ER+ and GI-II disease (GF)) or bad factor ( N+ or GIII or ER- disease (BF)).
To determine the relationship between the biological variables (hormone receptor status, grading, Laminin receptor, and c-erbB2) and the clinical outcome of the disease in these patients.
OUTLINE This is a randomized unicenter study. Patients are randomized to 1 o 2 treatment arms.
Arm 1: patients undergo conservative surgery with axillary lymphnodes removal Arm 2: patients undergo conservative surgery without axillary lymphnodes removal Post-operative adjuvant strategy was previously described.
Patients are followed every 4 months for the first two years, every 6 months for the following two years, and then annually thereafter.
PROJECT ACCRUAL 600 patients will be accrued for this study over 4 years
ELIGIBILITY Ages eligible for study: 18-65 years Genders eligible for study: female
- Conditions
- Female Breast Neoplasms, Carcinoma, Ductal, Breast
- Being tested
- axillary dissection
- Keywords
- breast cancer, axillary dissection
- Medical subject headings
- Carcinoma, Ductal, Breast, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axillary dissectionProcedure or surgery
Conservative breast surgery with or without axillary dissection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: breast surgery with axillary lymphnodes removal | Experimental | Not described Receives: Procedure: axillary dissection |
| Arm 2: breast surgery without axillary lymphnodes removal | Experimental | Not described Receives: Procedure: axillary dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in breast cancer mortality and overall survival between the two arms
Measured: median follow-up time: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startMay 1998
- Primary completionMay 2003
- Study completionMay 2003
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 Female Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe 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
- 565 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Agresti, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Investigators
- Roberto Agresti, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508546
- Sponsor's protocol ID
- 09/98
- Status last verified
- Jan 2012
- First submitted
- 15 Dec 2011
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Agresti R, Sandri M, Capri G, Bianchi G, Triulzi T, Lozza L, Trecate G, Trapani A, Ferraris C, Paolini B, Menard S, Greco M, Folli S, Tagliabue E. Axillary surgery versus no-axillary staging in T1N0 breast cancer: 20-year follow-up of the INT 09/98 randomized clinical trial. Br J Surg. 2025 Mar 4;112(3):znae311. doi: 10.1093/bjs/znae311.
PubMed 40042985
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Surgery With or Without Axillary Lymphnode Removal in Treating Women With T1N0 Breast Cancer
- ClinicalTrials.gov ID
- NCT01508546
- Acronym / sponsor ID
- 09/98
- Conditions
- Female Breast Neoplasms, Carcinoma, Ductal, Breast
- Keywords
- breast cancer, axillary dissection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 565 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- May 1998
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 12 Jan 2012 (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
Axillary surgery is still fundamental part of breast cancer (BC) management for adjuvant treatment planning.
Purpose
Randomized phase III trial to compare the effectiveness of surgical therapy with or without axillary dissection following conservative treatment in women with stage I breast cancer.
To determine the possibility to avoid axillary surgery in patients with early breast cancer, finding an alternative method to define the need of adjuvant treatment without compromising long-term disease control.
Detailed description
OBJECTIVES:
To compare the efficacy of conservative surgery, with or without axillary lymphnode removal (quadrantectomy with axillary dissection (QUAD) vs. quadrantectomy alone (QU)) followed by adjuvant treatment.
To plan no adjuvant therapy vs. adjuvant therapy (eA+CMF+TAM regimen) based on a biological panel of the primary tumor in the QU group (defined as good panel (GP) ( ER+, and up to one unfavourable features (G3, Her2+++, Laminin Receptor+) or bad panel (BP)(ER-, or ER+ and more than one unfavourable features), whereas in QUAD group based on good factor ( N-, ER+ and GI-II disease (GF)) or bad factor ( N+ or GIII or ER- disease (BF)).
To determine the relationship between the biological variables (hormone receptor status, grading, Laminin receptor, and c-erbB2) and the clinical outcome of the disease in these patients.
OUTLINE This is a randomized unicenter study. Patients are randomized to 1 o 2 treatment arms.
Arm 1: patients undergo conservative surgery with axillary lymphnodes removal Arm 2: patients undergo conservative surgery without axillary lymphnodes removal Post-operative adjuvant strategy was previously described.
Patients are followed every 4 months for the first two years, every 6 months for the following two years, and then annually thereafter.
PROJECT ACCRUAL 600 patients will be accrued for this study over 4 years
ELIGIBILITY Ages eligible for study: 18-65 years Genders eligible for study: female
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: breast surgery with axillary lymphnodes removal | Experimental | Procedure: axillary dissection |
| Arm 2: breast surgery without axillary lymphnodes removal | Experimental | Procedure: axillary dissection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women with T1N0M0 invasive breast cancer
- 18-65 years
Key exclusion criteria (2 listed)
- bilateral breast cancer
- no other prior or concurrent malignancy except basal cell carcinoma
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 |
|---|---|---|
| axillary dissectionConservative breast surgery with or without axillary dissection | Procedure or surgery | Arm 1: breast surgery with axillary lymphnodes removal, Arm 2: breast surgery without axillary lymphnodes removal |
Primary outcome
Difference in breast cancer mortality and overall survival between the two arms
Time frame: median follow-up time: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.
- Derived from this study: PubMed 40042985Agresti R, Sandri M, Capri G, Bianchi G, Triulzi T, Lozza L, Trecate G, Trapani A, Ferraris C, Paolini B, Menard S, Greco M, Folli S, Tagliabue E. Axillary surgery versus no-axillary staging in T1N0 breast cancer: 20-year follow-up of the INT 09/98 randomized clinical trial. Br J Surg. 2025 Mar 4;112(3):znae311. doi: 10.1093/bjs/znae311.
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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.
Roberto Agresti, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan
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 axillary dissection in people with Female Breast Neoplasms and Carcinoma, Ductal, Breast, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 12 Jan 2012. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in breast cancer mortality and overall survival between the two arms (time frame: median follow-up time: 10 years). 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 NCT01508546, 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 12 Jan 2012.