Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
Inclusion Criteria:
- Histologically confirmed invasive cancer of the breast
- Clinically or radiologically measureable disease in the breast after diagnostic
biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)
- No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had
prior chemotherapy or prior radiation therapy to the ipsilateral breast for this
malignancy. Prior bis-phosphonate therapy is allowed
- Age ≥18 years
- ECOG performance status 0-1
- Willing to undergo core biopsy of the primary breast lesion to assess baseline
biomarkers
- Non-pregnant and non-lactating
- No ferromagnetic prostheses. Patients who have metallic surgical implants that are not
compatible with an MRI machine are not eligible.
- Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL
Screening Consent)
- Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any
N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV,
where supraclavicular lymph nodes are the only sites metastasis
- Any tumor ER/PgR status, any HER-2/neu status as measured by local hospital pathology
laboratory and meets any tumor assay profile described in protocol section 4.1.2F
- Normal organ and marrow function: Leukocytes ≥ 3000/?L, Absolute neutrophil count ≥
1500/?L, Platelets ≥ 100,000/?L, Total bilirubin within normal institutional limits,
unless patient has Gilbert's disease, for which bilirubin must be ≤ 2.0 x ULN,
AST(SGOT)/ALT (SGPT) ≤ 1.5 x institutional ULN, creatinine < 1.5 x institutional ULN
- No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear
imaging or echocardiography) must by ≥ 50%
- No clinical or imaging evidence of distant metastases by PA and Lateral CXR,
Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline
phosphatase
- Tumor assay profile must include on of the following: MammaPrint High, any ER status,
any HER2 status, or MammaPrint Low, ER negative (<5%), any HER2 status, or MammaPrint
Low, ER positive, HER2/neu positive by any one of the three methods used (IHC, FISH,
TargetPrint?)
- Ability to understand and willingness to sign a written informed consent document
(I-SPY 2 TRIAL Consent #2)
Exclusion Criteria:
- Use of any other investigational agents within 30 days of starting study treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to the study agent or accompanying supportive medications.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 9/20/22. Questions regarding updates should be directed to the study team contact.