FRANCE CLINICAL TRIAL
LASERBREAST1: Local Treatment by Thermic Destruction of Primitive Breast Cancer
Purpose of the LASERBREAST1 Clinical Trial
The primary purpose of LASERBREAST1 Clinical Trial is to evaluate the rate of complete tumor ablation (destruction by laser) of breast cancers that are less than or equal to 2 centimeters. The trial also studies the correlation between post-laser ablation imaging (e.g., MRI, ultrasound and mammography) with post-surgical excision (e.g., lumpectomy) pathology in detecting any residual tumor.
More information on the trial can be found at: www.ClinicalTrials.gov (Identifier: NCT01706016).
Who May Qualify
The LASERBREAST1 Clinical Trial is open to subjects who generally meet the following criteria:
- Females between the ages of 18 to 80 years old
- Biopsy confirmed breast cancer tumor that is 2.0 cm or smaller
- Breast tumor that is well visualized on MRI and ultrasound or mammography
- Not pregnant or planning to conceive a child during clinical trial
Qualified subjects in the LASERBREAST1 Clinical Trial will receive comprehensive imaging pre-and post-laser ablation (breast MRI, ultrasound, mammography), laser ablation and surgical excision of the tumor. The post-ablation imaging and surgery will occur at or around 28 days following laser ablation. A sentinel lymph node biopsy, if indicated, as part of normal standard of care, will be performed at the time of surgery. Following surgery, the subject will proceed with recommended adjuvant or systemic therapy (i.e., radiation and/or chemotherapy). The subject will return for annual follow-up visits with their physician.
TELL A FRIEND
Do you have a friend or family member who has recently been diagnosed with early-stage breast cancer or a benign tumor? You can tell them about Novilase Breast Therapy for treatment of breast tumors.
Tell them about the Novilase website today by sending an email using this link.
AP-HP Hôpital Lariboisière [Active]
Sandra Bendavid, M.D. / Vinciane Place, M.D.
2 rue Ambroise Parè
77010 Paris, France
Institut Gustave-Roussy [Active]
Jean-Rèmi Garbay, M.D. / Corinne Balleyguier, M.D. / Sandra Canale, M.D.
114 rue Edouard Vaillant
94805 Villejuif, France