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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
| Bristol-Myers Squibb | INDUSTRY |
This is a multicenter, open-label, phase II trial to assess the efficacy of the GAT neoadjuvant regimen in patients with stage III breast cancer.
2 treatment cycles of chemotherapy (one cycle = 2 weeks) must be administered to each patient before breast surgery.
The required number of patients has been calculated following Simon's method. 43 patients will be enrolled in two phases: first, 29 patients must be enrolled, and at least 2 pathological complete responses obtained. Patients recruitment will continue until 43 patients have been enrolled. Assumptions are that there is a 95% probability to obtain a rate of pathological complete responses of at least 10%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine + Adriamycine + Paclitaxel | Experimental | Neoadjuvant chemotherapy consisted of adriamycine 40 mg/m2, administered on day 1 as an i.v. infusion. Paclitaxel 150 mg/m2 was administered on day 2 as an i.v infusion followed by gemcitabine 2000 mg/m2 as an i.v. infusion. The three drugs were administered every two weeks for 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug |
|
| |
| Adriamycine |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) rate | pCR is defined as no invasive cells identifiable in breast sections at surgery. Response will be measured by physical exam and breast imaging before surgery and will be evaluated according to the World Health Organization (WHO) criteria. Pathological response after surgery, will be based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in the breast and in the axilla lymph nodes. | Up to week 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Tumor response is defined as the percentage of patients with a complete or partial response out of the patients who had measurable disease at baseline. | Up to week 12 |
| Conservative surgery rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Hospital Miguel Servet | Study Director |
| Study Director | Complejo Hospitalrio de Jaén | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Hospital Universitario Marqués de Valdecilla |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22634531 | Result | Sanchez-Rovira P, Anton A, Barnadas A, Velasco A, Lomas M, Rodriguez-Pinilla M, Ramirez JL, Ramirez C, Rios MJ, Castella E, Garcia-Andrade C, San Antonio B, Carrasco E, Palacios JL. Classical markers like ER and ki-67, but also survivin and pERK, could be involved in the pathological response to gemcitabine, adriamycin and paclitaxel (GAT) in locally advanced breast cancer patients: results from the GEICAM/2002-01 phase II study. Clin Transl Oncol. 2012 Jun;14(6):430-6. doi: 10.1007/s12094-012-0820-4. |
| Label | URL |
|---|---|
| Description Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D004317 | Doxorubicin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Drug |
|
|
| Paclitaxel | Drug |
|
|
To determine the percentage of conservative surgery rate versus other surgery
| Up to week 15 |
| The Number of Participants Who Experienced Adverse Events (AE) | According to the Common Terminology Criteria for Adverse Events (CTCAE) version 2.0 | Through study treatment up to surgery |
| Disease-free survival | Time from the start of treatment to the progression of the disease (if it happens) | Up to 5 years since surgery |
| Tissue molecular markers and their correlation with response | Evaluation of changes in the tumor marker profile before and after treatment in tumor samples obtained before and after chemotherapy treatment. | Up to week 15 |
| Santander |
| Cantabria |
| 39008 |
| Spain |
| Hospital Universitario Fundación Alcorcón | Alcorcón | Madrid | 28922 | Spain |
| Complejo Hospitalario Unviesitario A Coruña | A Coruña | 15006 | Spain |
| Hospital Infanta Cristina | Badajoz | 06080 | Spain |
| Complejo Hospitalario de Jaén | Jaén | 23007 | Spain |
| Hospital Universitario La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |