Neoadjuvant Treatment of Triple Negative Breast Cancer Patients With Docetaxel and Carboplatin to Assess Anti-tumor Activity
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/13/2018 |
| Start Date: | July 7, 2014 |
| End Date: | May 31, 2019 |
| Contact: | Foluso Ademuyiwa, M.D., MPH |
| Email: | bisiademuyiwa@wustl.edu |
| Phone: | 314-362-7201 |
A Co-clinical Trial in Triple Negative Breast Cancer Patients With Genoproteomic Discovery
This is a single arm open label phase II study in women with clinical stage 2 or 3 triple
negative breast cancer to assess the anti-tumor activity (in terms of pathologic complete
response rate) of neoadjuvant docetaxel in combination with carboplatin. Patient derived
xenografts will also be developed simultaneously for the purposes of genoproteomic analysis.
Please note that Baylor College of Medicine (BCM) has a parallel study the same as this
study. Baylor is expected to enroll approximately 19 participants that have complied with the
inclusion and exclusion criteria for this study (excluded participants from BCM will include
male participants or participants with inflammatory breast cancer). The investigators will
pool participants and data from the BCM study and the study at Washington University School
of Medicine. Pooling the data will potentially improve statistical power.
negative breast cancer to assess the anti-tumor activity (in terms of pathologic complete
response rate) of neoadjuvant docetaxel in combination with carboplatin. Patient derived
xenografts will also be developed simultaneously for the purposes of genoproteomic analysis.
Please note that Baylor College of Medicine (BCM) has a parallel study the same as this
study. Baylor is expected to enroll approximately 19 participants that have complied with the
inclusion and exclusion criteria for this study (excluded participants from BCM will include
male participants or participants with inflammatory breast cancer). The investigators will
pool participants and data from the BCM study and the study at Washington University School
of Medicine. Pooling the data will potentially improve statistical power.
Inclusion Criteria:
- Newly diagnosed clinical stage II or III breast cancer with complete surgical excision
of the breast cancer after neoadjuvant chemotherapy as the treatment goal.
- Patients with PR+ tumors are allowed.
- HER2 negative by FISH or IHC staining 0 or 1+.
- ER less than Allred score of 3 or less than 1% positive staining cells in the invasive
component of the tumor
- Tumor size at least 2cm in one dimension by clinical or radiographic exam (WHO
criteria). Patients with palpable lymph nodes may be enrolled regardless of tumor
size.
- At least 18 years of age.
- ECOG performance status ≤ 2
- Normal bone marrow and organ function as defined below:
- Leukocytes ≥ 3,000/mcL
- Absolute neutrophil count ≥ 1,500/mcl
- Platelets ≥ 100,000/mcl
- Serum bilirubin within (or under ) normal limits (OR total bilirubin ≤ 3.0 x IULN
with direct bilirubin within normal range in patients with well documented
Gilbert Syndrome)
- AST(SGOT)/ALT(SGPT) within (or under ) normal limits
- Creatinine clearance ≥ 60 mL/min/1.73 m2
- Patients may be pre- or post-menopausal. Women of childbearing potential must agree to
use adequate contraception (hormonal or barrier method of birth control, abstinence)
prior to study entry and for the duration of study participation. Should a woman
become pregnant or suspect she is pregnant while participating in this study, she must
inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent
document (or that of legally authorized representative, if applicable).
- If consenting to participate in the optional PET/MR imaging sub-study, the patient
must be able to tolerate PET/MRI with intravenous contrast administration and must
complete the applicable MRI screening evaluation form
Exclusion Criteria:
- Prior systemic therapy for the indexed breast cancer.
- A history of other malignancy ≤ 5 years previous with the exception of basal cell or
squamous cell carcinoma of the skin which were treated with local resection only or
carcinoma in situ of the cervix.
- Patients with bilateral or inflammatory breast cancer.
- Currently receiving any other investigational agents.
- A history of allergic reactions attributed to compounds of similar chemical or
biologic composition to docetaxel or carboplatin.
- 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.
- Pregnant and/or breastfeeding. Patient must have a negative serum pregnancy test
within 7 days of study entry if premenopausal.
- Known HIV-positivity.
- Sentinel lymph node biopsy
- For patients who agree to participate in PET/MR imaging:
- renal insufficiency (glomerular filtration rate (GFR) < 30 mL/min/1.73 m2)
measured within the past 60 days which precludes safe administration of the
contrast agent
- on dialysis
- prior allergic reaction to gadolinium-based MR contrast agents
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-362-7201
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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