Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer - Full Text View

Sponsor:	Centre hospitalier de l'Université de Montréal (CHUM)
Information provided by:	Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:	NCT00909441

Purpose

Title of Study: Sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer.

Objectives of the study:

Primary objective

Evaluate the false negative rate of sentinel node biopsy in breast cancer patients presenting with positive nodal disease, proven by ultrasound guided fine needle aspiration or core biopsy, following neoadjuvant chemotherapy.
Evaluate the technical success rate of sentinel node biopsy in breast cancer patients presenting with positive nodal disease, proven by ultrasound guided fine needle aspiration or core biopsy, following neoadjuvant chemotherapy.

Secondary objectives

Evaluate the accuracy of sentinel node biopsy in the subgroup of patients that have achieved clinical and radiological complete response.
Evaluate the accuracy of clinical examination of the axilla in identifying the presence of residual disease in the axilla following neoadjuvant chemotherapy in biopsy proven node positive breast cancer patients.
Evaluate the accuracy of ultrasound examination of the axilla in identifying the presence of residual disease in the axilla following neoadjuvant chemotherapy in biopsy proven node positive breast cancer patients.

Number of patients:

N = 509

Population:

Patients with unresected breast cancer that are eligible for neoadjuvant chemotherapy that present with biopsy proven positive axillary nodes.

Study duration:

From February 2009 to February 2012 - 3 years

Condition	Intervention	Phase
Breast Cancer Invasive Breast Cancer	Procedure: Sentinel Lymph Node Biopsy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer: A Multi-Institutional Prospective Study Furthering the Treatment of Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Ultrasound

U.S. FDA Resources

Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:

The false negative rate of sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer. [ Time Frame: 4-7 months ] [ Designated as safety issue: Yes ]
The technical success of sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer. [ Time Frame: 4-7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Accuracy of clinical evaluation in determining the presence of residual disease following neoadjuvant chemotherapy in biopsy proven node positive breast cancer. [ Time Frame: 0-1 month and 3-6 months ] [ Designated as safety issue: No ]
Accuracy of ultrasound evaluation in determining the presence of residual disease following neoadjuvant chemotherapy in biopsy proven node positive breast cancer. [ Time Frame: 0-1 month and 3-6 months ] [ Designated as safety issue: No ]
Evaluate the false negative rate and technical success rate of sentinel node biopsy in the subgroup of patients that have achieved clinical and radiological complete response. [ Time Frame: 4-7 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	509
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Sentinel node biopsy is a technique in which a radioactive isotope is injected in the breast, with or without blue dye. These substances will then migrate and concentrate in the first nodes in the axilla that drain the breast: The sentinel nodes. These nodes (usually one to four nodes) are then evaluated for the presence of cancer cells.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Conditions for patient eligibility

Inclusion criteria:

Patients must be female.
Patients must be 18 years of age or older.
Patients with T1-3, N1 breast cancer. Stage IIA, IIB, IIIA (only T3N1) breast cancer. Clinical N0 are accepted if there is biopsy proven positive axillary nodes.
Patients that have biopsy proven positive axillary disease by core needle biopsy or fine needle aspiration.
Patients must be chemotherapy naïve.
Patients that accept to undergo neoadjuvant chemotherapy; patients are eligible until four weeks after day one of the first neoadjuvant treatment cycle.
Patients with bilateral breast cancer are eligible. Sentinel node biopsy is allowed on the contralateral breast if there is no disease in the axilla prior to chemotherapy.
Patients that understand, accept and have signed the approved consent form.
Patients with previous excisional biopsy, ipsilateral tumorectomy and breast implants are eligible.

Exclusion Criteria:

Patients with inflammatory breast cancer.
Patient with stage IIIA (except T3N1), IIIB, IIIC or IV. Clinical N2-3 disease are excluded.
Patients that have had previous axillary dissection or an axillary sentinel node biopsy
Patients that have had previous radiotherapy to the axillary nodes
Patients that have had mammary reduction
Patients that are medically unfit to receive chemotherapy, as evaluated by the treating physician.
If the injection of blue is planned, patients with hypersensitivity or allergy to isosulfan blue, Patent blue or methylene blue or radiocolloid dye.
Patients who are pregnant or breastfeeding .
Psychiatric or addictive disorders or other conditions that preclude the patient from meeting the study requirements.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909441

Contacts

Contact: Nicole Tremblay, Ph.D.	514-890-8000 ext 15535	nicole.g.tremblay.chum@ssss.gouv.qc.ca
Contact: Ana Lydia Tkalec, B.Sc.	514-890-8000 ext 14186	ana.lydia.tkalec.chum@ssss.gouv.qc.ca

Locations

Canada, Quebec
Centre de recherche du Centre hospitalier de l'Université de Montréal	Recruiting
Montréal, Quebec, Canada, H2W 1T7
Contact: Nicole Tremblay, Ph.D. 514-890-8000 ext 15535 nicole.g.tremblay.chum@ssss.gouv.qc.ca

Sponsors and Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

Principal Investigator:

Jean-François Boileau, MD FRCSC

Centre Hospitalier de l'Université de Montréal

More Information

No publications provided

Responsible Party:	Centre hospitalier de l'Université de Montréal (CHUM) ( Jean-François Boileau )
Study ID Numbers:	CHUM-08.224
Study First Received:	May 25, 2009
Last Updated:	May 27, 2009
ClinicalTrials.gov Identifier:	NCT00909441 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):

Breast Cancer
Node Positive Breast Cancer
Sentinel Lymph Node Biopsy

Breast Surgery
Axillary Lymph Node Dissection
Neoadjuvant Chemotherapy

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 20, 2009