Study to Identify Molecular Mechanisms of Clinical Resistance to Chemotherapy in Triple Negative Breast Cancer Patients
Completed
Conditions studied: Triple Negative Breast Cancer
In brief
This is a multicenter translational study to understand therapeutic resistance in patients undergoing standard chemotherapy for triple negative breast cancer. In the neoadjuvant setting, biopsy tissue samples from primary tumor will be collected and banked before the start of chemotherapy and after the completion of the treatment (post-chemotherapy and at the time of surgery). In the metastatic setting, tissue samples from metastatic lesions will be collected and banked before the start of chemotherapy and at the time of tumor progression. Additionally, blood samples will be drawn before treatment initiation (baseline) and at different time points during treatment. All samples will be stored in the Biological Resource Repository.
Key facts
- Study ID
- NCT01276899
- Run by
- Jewish General Hospital
- People needed
- 80
- Starts
- 2010-09-01
- Last updated by the study team
- 2022-06-02
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Neoadjuvant setting
- Histologically confirmed diagnosis of adenocarcinoma of the breast
- Patient candidate for neoadjuvant chemotherapy (taxane-based)
- Triple negative (ERnegative, PRnegative and Her2negative as defined by local standards)
- Normal coagulation profile; including INR/ PTT ≤ 1.5 x ULN.
- ECOG 0,1 or 2
- Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained.
- Able to adhere to the study visit schedule and other protocol requirements.
- Metastatic setting
- Patients with histologically confirmed primary adenocarcinoma of the breast
- Metastatic (stage IV) disease at initial diagnosis or following previous diagnosis of primary breast cancer
- At least one metastatic site accessible for biopsy.
- ER-negative, PgR negative and HER2 negative as per local standards
- Scheduled to receive chemotherapy for triple negative metastatic breast cancer.
- Measurable disease (at least one unidimensionally measurable lesion)
- Normal coagulation profile; including INR/ PTT ≤ 1.5 x ULN.
- ECOG 0,1 or 2
- Life expectancy of 12 or more weeks.
- Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained.
- Able to adhere to the study visit schedule and other protocol requirements
You may not qualify if…
- Neoadjuvant setting
- Positive for ER, PR or Her2 as defined by local standards
- Clinical or radiological evidence of metastatic disease
- Inadequate or unusable tissue as the only tissue available for biopsy
- Other non-malignant systemic disease to preclude treatment with chemotherapy regimen or prevent follow-up
- Diagnosis of inflammatory breast cancer
- Known infection with HIV or hepatitis
- Metastatic setting
- Patients with ER+, PR+ or HER2+ tumors demonstrated by local standards
- Inadequate or unusable tissue as the only tissue available for biopsy
- Other non-malignant systemic disease to preclude treatment with standard chemotherapy regimen or prevent follow-up
- Abnormal coagulation profile
- The planned concurrent administration of therapies (e.g. palliative radiotherapy) that target metastatic sites accessible for biopsy
- Known infection with HIV or hepatitis
Where it is running
- John H. Stroger, Jr. Hospital of Cook County — Chicago, Illinois, United States
- Centre Hospitalier de l'Université de Montréal -- Hotel-Dieu — Montreal, Quebec, Canada
- Centre Hospitalier de l'Université de Montréal- Notre-Dame — Montreal, Quebec, Canada
- Hôpital Royal Victoria — Montreal, Quebec, Canada
- Hôpital Sacré-Coeur — Montreal, Quebec, Canada
- Jewish General Hospital — Montreal, Quebec, Canada
- St-Mary's Hospital Center — Montreal, Quebec, Canada
- Hopital du St-Sacrement — Québec, Canada
Full record on ClinicalTrials.gov
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