RESTORE-2 Patient Profile
What Were the Patient Criteria for the RESTORE-2 Study? Key Inclusion/Exclusion Criteria
Patients who were enrolled in this clinical study were required to meet certain inclusion criteria.
The following is not a complete list of patient inclusion criteria:
Women with a history of small breast carcinoma (tumor ≤3 cm in largest dimension)
Surgical or endoscopic segmental mastectomy or quadrantectomy (lumpectomy)
Clean surgical margins
No prosthesis in breast(s) to undergo treatment
Ability to undergo liposuction
Last treatment for breast cancer ≥ 12 months prior to enrollment with absence of recurrence (patients on anti-estrogen adjuvant therapy are NOT excluded)
No evidence of recurrence of cancer based on mammogram or breast exam prior to enrollment
A minimum of two-thirds of the breast is remaining post Breast Conservation Therapy
Patients did
not
qualify if they met any of the following exclusion criteria (also not a complete list):
History of autoimmune disorder (e.g., Systemic Lupus Erythematosus [SLE])
History of connective, metabolic or atrophic skin disease
History of keloid scarring
Chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days prior to enrollment
Life expectancy ≤ 2 years
Recurrence or active malignancy requiring radiation or surgical treatment ≤12 months prior to enrollment
Presence of any other known malignancy
Body Mass Index (BMI) >30
Plan to undergo weight reduction surgery or foresee any significant weight changes during the study (defined as changes in BMI >5 compared to baseline)
>> Learn More about the RESTORE-2 Study Status