Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer (LABC)
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| ClinicalTrials.gov Identifier: NCT00820690 |
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Recruitment Status : Unknown
Verified August 2015 by Barretos Cancer Hospital.
Recruitment status was: Active, not recruiting
First Posted : January 12, 2009
Last Update Posted : August 5, 2015
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| Condition or disease | Intervention/treatment |
|---|---|
| Breast Cancer | Drug: doxorubicin Drug: cyclophosphamide Drug: paclitaxel Procedure: Surgery |
Locally advanced breast cancer is a common condition in development countries. Neoadjuvant chemotherapy gives the opportunity to identify genetic signatures associated with objective clinical and pathological complete responses.
Patients will receive doxorubicin/cyclophosphamide with paclitaxel. Tumor samples collected before and after chemotherapy will be analyzed.
| Study Type : | Observational |
| Actual Enrollment : | 80 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Gene Expression Signature and Immunohistochemical Markers Associated With Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer |
| Study Start Date : | July 2008 |
| Actual Primary Completion Date : | April 2012 |
| Estimated Study Completion Date : | September 2017 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Clinical stage III
Women with invasive breast cancer; clinical stage III, condition to receive neoadjuvant chemotherapy based in doxorubicin/ cyclophosphamide and paclitaxel followed by surgery (mastectomy and axillary lymph node dissection)
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Drug: doxorubicin
4 cycles AC: doxorubicin 60mg/m2
Other Name: clinical and radiologic response Drug: cyclophosphamide 4 cycles AC: cyclophosphamide 600mg/m2
Other Name: clinical and radiologic response Drug: paclitaxel 4 cycles T: paclitaxel 175mg/m2 after 4 AC
Other Name: clinical, radiologic and pathologic response Procedure: Surgery The surgery will be performed 30 days after the chemotherapy. The correlation between clinical, radiologic and pathologic response will be reported. The oncoplastic surgery rate will be reported Other Names:
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- Clinical objective and pathological responses to chemotherapy [ Time Frame: 8 months ]
Clinical and radiological examinations to be performed before chemotherapy, after the 4 cycle of AC and before surgery.
Pathologic evaluation to be performed 30 days after the last cycle of chemotherapy, i.g. after surgery.
- Clinical, radiologic and pathologic correlation [ Time Frame: 3 years ]tumor concordance measurement among pre-operative physical examination (PE), mammography (MG), ultrasound (US), breast MRI and post-operative pathologic measurement concordance with PE, MG, US and MRI
- Surgery [ Time Frame: 5 years ]The use and security of oncoplastic surgery after neoadjuvant chemotherapy
- Overall actuarial survival [ Time Frame: 5 years ]
- Pathologic complete response [ Time Frame: 9 months ]Pathologic complete response after neoadjuvant chemotherapy
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Women with locally advanced women breast cancer
- Histology: ductal ou lobular invasive histology
- Agreement to take part in the study and signature of the informed consent
- Clinical condition to receive doxorubicin/cyclophosphamide and paclitaxel
- ECOG 0 or I
Exclusion Criteria:
- Not clinical stage III
- Inflammatory breast cancer
- Previous treatment
- Previous diagnosis of cancer (except basal cell or squamous cell skin carcinoma and non-invasive cervical carcinoma)
- Pregnancy
- Absence of clinical condition to receive chemotherapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820690
| Brazil | |
| Barretos Cancer Hospital | |
| Barretos, São Paulo, Brazil, 14.784-400 | |
| Study Chair: | Maria Aparecida A Koike Folgueira, MD, PhD | Faculdade de Medicina - Universidade de São Paulo |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Barretos Cancer Hospital |
| ClinicalTrials.gov Identifier: | NCT00820690 |
| Other Study ID Numbers: |
135/2008 |
| First Posted: | January 12, 2009 Key Record Dates |
| Last Update Posted: | August 5, 2015 |
| Last Verified: | August 2015 |
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neoadjuvant chemotherapy advanced breast cancer microarray correlation analysis oncoplastic surgery |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Cyclophosphamide Doxorubicin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |