Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT00866905
Eligibility Criteria:
Inclusion Criteria:
1. Female patients, age ≥18 years.
2. Histologically confirmed invasive adenocarcinoma of the breast.
3. Primary palpable disease confined to a breast and axilla on
physical examination. For patients without clinically suspicious
axillary adenopathy, the primary tumor must be larger than 2 cm
in diameter by physical exam or imaging studies (clinical T2-T3,
N0-N1, M0). For patients with clinically suspicious axillary
adenopathy, the primary breast tumor can be any size (clinical
T1-3, N1-2, M0). (T1N0M0 lesions are excluded.)
4. Patients without clearly defined palpable breast mass or axillary
lymph nodes but radiographically measurable tumor masses are
acceptable. Accepted procedures for measuring breast disease
are mammography, MRI, and breast ultrasound. This will need to
be re-evaluated after 3 cycles and prior to surgery.
5. Eastern Cooperative Oncology Group performance status (ECOG
PS) 0-2.
6. No metastatic disease, as documented by complete staging workup
* 6 weeks prior to initiation of study treatment.
7. No previous treatment for breast cancer.
8. HER2-negative tumor status. HER2-negative is defined as:
* Immunohistochemical (IHC) 0, IHC 1+ OR
* IHC 2+ or IHC 3+ must be confirmed as FISH (fluorescence in situ
hybridization) negative (defined by ratio \<2.2).
9. Adequate hematologic function with:
* Absolute neutrophil count (ANC) \>1500/μL.
* Platelets ≥100,000/μL.
* Hemoglobin ≥10 g/dL.
10. Adequate hepatic function with:
* Serum bilirubin ≤ the institutional upper limit of normal (ULN).
* Aspartate aminotransferase (AST) ≤2.5 x institutional ULN.
* Alanine aminotransferase (ALT) ≤2.5 x institutional ULN.
11. Adequate renal function with serum creatinine ≤1.5 x ULN.
12. Estrogen and progesterone receptor status in the primary tumor
known or pending at the time of study registration.
13. Knowledge of the investigational nature of the study and ability to
provide consent for study participation.
14. For patients who had, or will have sentinel lymph node and/or
axillary dissection prior to initiation of study treatment, completion
at least 4 weeks prior to starting study treatment and well-healed
wound
15. Bilateral, synchronous breast cancer is allowed if one primary
tumor meets the inclusion criteria.
16. Sufficient archived breast tumor specimen available at baseline
for the Oncotype DX assay.
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Exclusion Criteria:
1. Inflammatory breast cancer.
2. Peripheral neuropathy (motor or sensory) ≥ grade 1 by the
Common Terminology Criteria for Adverse Events version 3.0
(CTCAE v 3.0).
3. Prior radiation that included ≥30% of major bone marrow containing
areas (pelvis, lumbar, spine).
4. Chronic use of cytochrome P450 (CYP) 3A4 inhibitors and use of
the following strong CYP3A4 inhibitors: ketoconazole,
itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir,
telithromycin, ritonavir, amprenavir, indinavir, nelfinavir,
delavirdine, and voriconazole. Use of these agents should be
discontinued at least 72 hours prior to initiation of study treatment.
5. Chemotherapy within 5 years of starting study treatment except
for low doses of agents used for anti-inflammatory indications
such as rheumatoid arthritis, psoriasis, and connective tissue
disorders. Although such doses and schedules cannot result in
myelosuppression, patients must discontinue this therapy while
they are receiving study treatment.
6. Known or suspected hypersensitivity to Cremophor®EL
(polyoxyethylated castor oil) or a drug formulated in
Cremophor®EL such as paclitaxel, or any other agent given in the
course of this study.
7. Pregnancy or breast-feeding. A negative serum pregnancy test
within 7 days prior to first study treatment (Day 1, Cycle 1) for all
women of childbearing potential is required. Patients of
childbearing potential must agree to use a birth control method
that is approved by their study physician while receiving study
treatment and for 3 weeks after their last dose of study treatment.
Patients must agree to not breast-feed while receiving study
treatment.
8. Concurrent treatment with an ovarian hormonal replacement
therapy or with hormonal agents such as raloxifene, tamoxifen or
other selective estrogen receptor modulator (SERM). Patients
must have discontinued use of such agents prior to beginning
study treatment.
9. History of malignancy treated with curative intent within the
previous 5 years with the exception of skin cancer, cervical
carcinoma in situ, or follicular thyroid cancer. Patients with
previous invasive cancers (including breast cancer) are eligible if
the treatment was completed more than 5 years prior to initiating
current study treatment, and there is no evidence of recurrent
disease.
10. Uncontrolled intercurrent illness including (but not limited to)
ongoing or active infection.
11. Chronic treatment with corticosteroid unless treatment was begun
\>6 months prior to study treatment and is at a low dose (≤20 mg
methylprednisolone or equivalent).
12. Use of any investigational agent within 30 days of administration
of the first dose of study drug.
13. Requirement for radiation therapy concurrent with neoadjuvant
study chemotherapy.
14. Concurrent treatment with any anti-cancer therapy other than
those agents used in this study.
15. Inability or unwillingness to comply with study procedures
including follow-up visits.
16. Mental condition or psychiatric disorder that would prevent patient
comprehension of the nature, scope, and possible consequences
of the study or that would limit compliance with study
requirements.
17. Any other disease(s), metabolic dysfunction, or findings from a
physical examination or clinical laboratory test result that would
cause reasonable suspicion of a disease or condition that
contraindicates the use of study drugs, that may affect the
interpretation of the results, or that renders the patient at high risk
from treatment complications
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Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00866905
Study Brief:
Protocol Section:
NCT00866905