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Breast CancerPhase 310-93NCT00002528

Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer

A Phase 3 study testing tamoxifen citrate, conventional surgery and radiation therapy in people with Breast Cancer, run by ETOP IBCSG Partners Foundation at 21 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Removing axillary lymph nodes may be effective in stopping the spread of breast cancer cells. It is not yet known if surgery to remove breast cancer is more effective with or without lymph node removal. Read more about this study

Who is it for?
Ages 60 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
tamoxifen citrate, conventional surgery and radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
473 participants
Where
21 sitesin 9 countries
Study dates
May 1993to Aug 2010
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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage I or IIA breast carcinoma that is considered operable
  • No prior axillary clearance or biopsy
  • Complete excisional biopsy of primary tumor without axillary clearance or biopsy allowed
  • Suspicious manifestations of metastatic disease (e.g., hot spots on bone scan or skeletal pain of unknown cause) must be proven benign
  • No bilateral breast cancer (any mass in contralateral breast must be proven benign by biopsy)
  • Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 60 and over

Sex:

  • Female

Menopausal status

  • Postmenopausal

Performance status:

  • Not specified

Hematopoietic:

  • WBC greater than 4,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.1 mg/dL
  • AST less than 60 U/L

Renal:

  • Creatinine less than 1.3 mg/dL

Cardiovascular:

  • Normal cardiac function
  • No history of congestive heart failure

Other:

  • No nonmalignant systemic disease that would preclude protocol therapy or prolonged follow-up
  • No psychiatric or addictive disorder that would preclude protocol therapy or informed consent
  • No other prior or concurrent malignancy except nonmelanomatous skin cancer or adequately treated carcinoma in situ of the cervix
  • Geographically accessible for follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy for breast cancer

Chemotherapy:

  • No prior chemotherapy for breast cancer

Endocrine therapy:

  • No prior endocrine therapy for breast cancer

Radiotherapy:

  • No prior radiotherapy for breast cancer

Surgery:

  • See Disease Characteristics

Trial locations and contacts

21 sites in 9 countries.

21 sites in 9 countries

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Anti-Cancer Council of Victoria, Melbourne

    Parkville, Victoria, 3050

  • Sir Charles Gairdner Hospital, Perth

    Perth, Western Australia, 6009

  • Royal Prince Alfred Hospital, Sydney

    Sydney, New South Wales, 2050

  • Newcastle Mater Misericordiae Hospital

    Waratah, New South Wales, 2298

Other trials in Australia

Italy5 sites

  • Centro di Riferimento Oncologico - Aviano

    Aviano, 33081

  • Spedali Civili

    Brescia, 25124

  • Presidio Ospedaliero-Gorizia

    Gorizia, 34170

  • Ospedale Civile Rimini

    Rimini, 47900

  • Ospedale San Eugenio

    Rome, 00144

Other trials in Italy

Switzerland5 sites

  • University Hospital

    Basel, CH-4031

  • Inselspital, Bern

    Bern, CH-3010

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9006

  • UniversitaetsSpital

    Zurich, CH-8091

Other trials in Switzerland

Hungary1 site

  • National Institute of Oncology

    Budapest, 1125

Other trials in Hungary

Israel1 site

  • Hadassah University Hospital

    Jerusalem, 91120

Other trials in Israel

New Zealand1 site

  • Auckland Adventist Hospital

    Auckland, 5

Other trials in New Zealand

Slovenia1 site

  • Institute of Oncology, Ljubljana

    Ljubljana, Sl-1000

Other trials in Slovenia

South Africa1 site

  • Groote Schuur Hospital, Cape Town

    Cape Town, 7925

Other trials in South Africa

Sweden1 site

  • Sahlgrenska University Hospital

    Gothenburg (Goteborg), S-413 45

Other trials in Sweden

About this study

Official title: Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.

RATIONALE: Removing axillary lymph nodes may be effective in stopping the spread of breast cancer cells. It is not yet known if surgery to remove breast cancer is more effective with or without lymph node removal.

PURPOSE: Randomized phase III trial to compare the effectiveness of breast surgery with or without removal of axillary lymph nodes in treating women who have stage I or stage IIA breast cancer.

Read the detailed description

OBJECTIVES:

  • Compare local and systemic disease-free survival, ipsilateral axillary relapse, occurrence of postmastectomy syndrome, and overall survival of elderly women with clinically operable stage I or IIA breast cancer who subsequently receive adjuvant tamoxifen after treatment with breast surgery with or without axillary node dissection.
  • Compare the toxicity of these regimens in these patients.
  • Compare the quality of life in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to whether they received prior primary surgery (yes vs no) and participating center.

  • Arm I: Patients undergo mastectomy, lumpectomy, or quadrantectomy with axillary clearance. Patients then receive oral tamoxifen for 5 years. Patients may also undergo sentinel node biopsy.
  • Arm II: Patients undergo surgery as in arm I without axillary clearance. Patients then receive oral tamoxifen for 5 years.

Patients in both arms who undergo breast-conserving surgery may receive optional radiotherapy for 5-6 weeks to the remaining breast tissue, chest, and lung. Upon recurrence in the conserved breast, patients undergo total mastectomy; those in arm II who experience ipsilateral axillary recurrence undergo surgical excision. Adjuvant tamoxifen and follow up are continued.

Quality of life is assessed.

Patients are followed every 3 months for 1 year, every 6 months while receiving tamoxifen, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,020 patients will be accrued for this study within approximately 5 years.

Conditions
Breast Cancer
Being tested
tamoxifen citrate, conventional surgery, radiation therapy, Axillary clearance
Keywords
stage I breast cancer, 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.

  • tamoxifen citrateDrug

    20 mg daily beginning within 6 weeks of surgery for 5 years or until relapse, whichever occurs first.

  • conventional surgeryProcedure or surgery

    Either total mastectomy or, optionally if the tumor was smaller than 5 cm, a breast conserving procedure (lumpectomy or quadrantectomy).

  • radiation therapyRadiation

    No radiotherapy is to be given after mastectomy. Radiotherapy is optional after breast conserving surgery according to prospectively determined guidelines within each institution. It should be given to the breast only and not to the draining node areas.

  • Axillary clearanceProcedure or surgery

    Axillary node dissection.

Study groups in NCT00002528
Study groupRoleWhat they receive
Surgery w/ axillary clearance, tamoxExperimentalEither a total mastectomy with axillary clearance, or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) with axillary lymph node dissection, and tamoxifen (20 mg) given after surgery for the duration of 5 years or until relapse.
Receives: Drug: tamoxifen citrate; Procedure: conventional surgery; Radiation: radiation therapy; Procedure: Axillary clearance
Surgery w/o axillary clearance, tamoxExperimentalEither a total mastectomy without axillary clearance, or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) without axillary lymph node dissection, and tamoxifen (20 mg) given after surgery for the duration of 5 years or until relapse.
Receives: Drug: tamoxifen citrate; Procedure: conventional surgery; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival

    Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first.

    Measured: 17 years from randomization

Secondary outcomes (3)

  1. Overall survival

    Time from randomization to death.

    Measured: 17 years from randomization

  2. Toxicity

    Side effects of treatment, especially surgery-related events.

    Measured: 17 years from randomization

  3. Quality of life

    Quality of life will be assessed by standard International Breast Cancer Study Group instruments

    Measured: 17 years from randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMay 1993
  3. Primary completionDec 2002
  4. Study completionAug 2010

Resources

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
473 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002528
Sponsor's protocol ID
CDR0000078383
Other IDs
IBCSG-10-93, EU-93013, NCI-F93-0008
Acronym
10-93
Status last verified
Jul 2012
First submitted
1 Nov 1999
Last updated
4 Apr 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Pestalozzi BC, Zahrieh D, Mallon E, Gusterson BA, Price KN, Gelber RD, Holmberg SB, Lindtner J, Snyder R, Thurlimann B, Murray E, Viale G, Castiglione-Gertsch M, Coates AS, Goldhirsch A; International Breast Cancer Study Group. Distinct clinical and prognostic features of infiltrating lobular carcinoma of the breast: combined results of 15 International Breast Cancer Study Group clinical trials. J Clin Oncol. 2008 Jun 20;26(18):3006-14. doi: 10.1200/JCO.2007.14.9336. Epub 2008 May 5.

    PubMed 18458044

  • International Breast Cancer Study Group; Rudenstam CM, Zahrieh D, Forbes JF, Crivellari D, Holmberg SB, Rey P, Dent D, Campbell I, Bernhard J, Price KN, Castiglione-Gertsch M, Goldhirsch A, Gelber RD, Coates AS. Randomized trial comparing axillary clearance versus no axillary clearance in older patients with breast cancer: first results of International Breast Cancer Study Group Trial 10-93. J Clin Oncol. 2006 Jan 20;24(3):337-44. doi: 10.1200/JCO.2005.01.5784. Epub 2005 Dec 12.

    PubMed 16344321

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tamoxifen citrate, conventional surgery and radiation therapy in people with Breast Cancer, run by ETOP IBCSG Partners Foundation at 21 sites in 9 countries.

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: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Australia, Italy, Switzerland, Hungary, Israel and 4 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 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?

Disease-free survival (time frame: 17 years from randomization). 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 NCT00002528, 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 4 Apr 2013.

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10-93 Clinical Trial NCT00002528 | AzTrials