Clinical trial · Interventional
Validate Gene Expression and Proteomic Signatures Predictive of Treatment for Response for Breast Cancer Patient
Phase 2 Randomized Study of Adriamycin & Docetaxel in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer Patients With Measurable Primary Breast Tumor to Validate Gene Expression & Proteomic Signatures Predictive of Treatment Response
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objectives 1. Validate our previously generated tumor gene expression and proteomic profiles in this independent sample to determine the predictive power to distinguish good from poor clinical and pathological responders to adriamycin or docetaxel. 2. Validate our previously generated plasma proteomic profiles in this independent sample to determine the predictive power to distinguish good from poor clinical and pathological responders to adriamycin and docetaxel. Secondary objectives 1. To correlate adriamycin and docetaxel pharmacokinetics with 1. Genetic polymorphisms of drug metabolizing enzymes and transporters, including MDR-1, Cyp3A, GSTs, and the nuclear receptors. 2. Drug toxicity and tumor response. 3. Peripheral mononuclear cell gene expression profiles 2. To study ondansetron pharmacokinetics and correlate that with genetic polymorphisms.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adriamycin | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adriamycin
- description
- Arm A: 4 cycles of adriamycin at 75mg/m2 3 weekly followed by surgery followed by 4 cycles of docetaxel at 75mg/m2 3 weekly
- interventionNames
- Drug: Adriamycin
- type
- EXPERIMENTAL
- label
- Docetaxel
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Clinical and pathological response rate
- timeFrame
- 12 weeks
- description
- Clinical and pathological response rate to four cycles of pre-operative chemotherapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
Patients may be included in the study only if they meet all of the following criteria:
* Female, age 18 years or above.
* Histologic or cytologic diagnosis of breast carcinoma.
* T2-4 breast cancer with measurable primary breast tumor, defined as palpable tumor with both diameters 2.0cm or greater as measured by caliper.
* Patients must not have received prior chemotherapy or hormonal therapy for the treatment of breast cancer.
* Karnofsky performance status of 70 or higher.
* Estimated life expectancy of at least 12 weeks.
* Adequate organ function including the following:
* Bone marrow:
* Absolute neutrophil (segmented and bands) count (ANC)\>= 1.5 x 10 9/L
* Platelets \>= 100 x 10 9/L
* Hepatic:
* Bilirubin \<= 1.5 x upper limit of normal (ULN),
* ALT or AST \<= 2.5x ULN, (or \<= 5 X with liver metastases)
* Renal:
* creatinine \<= 1.5x ULN
* Left ventricular ejection fraction \>= 50%
* Signed informed consent from patient or legal representative.
* Patients with reproductive potential must use an approved contraceptive method if appropriate (eg, intrauterine device, birth control pills, or barrier device) during and for three months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
Exclusion Criteria:
Patients will be excluded from the study for any of the following reasons:
* Prior treatment for locally advanced or metastatic breast cancer.
* Treatment within the last 30 days with any investigational drug.
* Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
* Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
* Pregnancy.
* Breast feeding.
* Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
* Poorly controlled diabetes mellitus.
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
* Symptomatic brain metastasis.
* History of significant neurological or mental disorder, including seizures or dementia.
* Peripheral neuropathy of CTC grade 2 or above (NCI CTC version 3).
* History of hypersensitivity to drugs formulated in Tween 80, the vehicle used for commercial docetaxel formulations.References
Publications (3)
- BACKGROUNDChang JC, Wooten EC, Tsimelzon A, Hilsenbeck SG, Gutierrez MC, Tham YL, Kalidas M, Elledge R, Mohsin S, Osborne CK, Chamness GC, Allred DC, Lewis MT, Wong H, O'Connell P. Patterns of resistance and incomplete response to docetaxel by gene expression profiling in breast cancer patients. J Clin Oncol. 2005 Feb 20;23(6):1169-77. doi: 10.1200/JCO.2005.03.156. PMID 15718313
- BACKGROUNDPetricoin EF, Ardekani AM, Hitt BA, Levine PJ, Fusaro VA, Steinberg SM, Mills GB, Simone C, Fishman DA, Kohn EC, Liotta LA. Use of proteomic patterns in serum to identify ovarian cancer. Lancet. 2002 Feb 16;359(9306):572-7. doi: 10.1016/S0140-6736(02)07746-2. PMID 11867112
- DERIVEDVoon PJ, Yap HL, Ma CY, Lu F, Wong AL, Sapari NS, Soong R, Soh TI, Goh BC, Lee HS, Lee SC. Correlation of aldo-ketoreductase (AKR) 1C3 genetic variant with doxorubicin pharmacodynamics in Asian breast cancer patients. Br J Clin Pharmacol. 2013 Jun;75(6):1497-505. doi: 10.1111/bcp.12021. PMID 23116553