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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
This is an open-label study that includes two substudies of random distribution. First,a sample of the primary tumor will be obtained and will be analyzed by an immunohistochemical technique to determine several markers.Depending on the expression of these markers, the patients will be characterize as group 1 (Luminal A phenotype) or group 2 (Basal phenotype) and a random assignment will be performed to standard or experimental treatment.
Group 1 (Luminal A):
EC x 4 -> D x 4
Group 2 (Basal):
EC x 4 -> DCb x 4
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Luminal A) Standard treatment | Active Comparator | Standard treatment: Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles. |
|
| Group 1 (Luminal A) Selective treatment | Experimental | Selective treatment: Postmenopausal patients: exemestane x 6 months Premenopausal patients: goserelin x 6 months + exemestane x 6 months |
|
| Group 2 (Basal) Standard treatment | Active Comparator | Standard treatment: Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles. |
|
| Group 2 (Basal) Selective treatment | Experimental | Selective treatment: Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epirubicin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Response for Basal Group 2 | This primary outcome only applies for the basal group 2 as per protocol. The pathological response in luminal group 1 was not pre-specified even as a Secondary Outcome. Pathological response was assessed after surgery, according to the Miller & Payne criteria, which stratifies the responses based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in breast and axilla. Grades 1-4 are categorised as a partial pathological response (pPR) and grade 5 was a complete pathological response (cPR). | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Rate | Clinical Response Rate was measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria for target lesions before surgery: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Up to week 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Hospital Miguel Servet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporació Sanitaria Parc Taulà | Sabadell | Barcelona | 08208 | Spain | ||
| Hospital Mutua de Terrassa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23053638 | Result | Alba E, Chacon JI, Lluch A, Anton A, Estevez L, Cirauqui B, Carrasco E, Calvo L, Segui MA, Ribelles N, Alvarez R, Sanchez-Munoz A, Sanchez R, Garcia-Asenjo JA, Rodriguez-Martin C, Escudero MJ, Albanell J. A randomized phase II trial of platinum salts in basal-like breast cancer patients in the neoadjuvant setting. Results from the GEICAM/2006-03, multicenter study. Breast Cancer Res Treat. 2012 Nov;136(2):487-93. doi: 10.1007/s10549-012-2100-y. Epub 2012 Oct 9. | |
| 22674146 |
| Label | URL |
|---|---|
| Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group | View source |
Not provided
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Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (Luminal A) Standard Treatment | Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles. |
| FG001 | Group 1 (Luminal A) Selective Treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cyclophosphamide | Drug |
|
|
| Docetaxel | Drug |
|
|
| Exemestane | Drug |
|
|
| Goserelin | Drug |
|
|
| Carboplatin | Drug |
|
|
| Breast Conservative Surgery Rate | All patients will undergo surgery within the expected period from the end of treatment with neoadjuvant therapy. The chosen surgical option will be collected in the Case Report Form (CRF) before starting the neoadjuvant treatment, depending on the characteristics Clinics of the patient at that time (conservative surgery or mastectomy). This information will be compared with definitive surgery, to analyze whether neoadjuvant treatment has contributed to increase the rate of conservative surgery. | Up to 24 weeks |
| Axillary Node Status at the Time of Surgery | All the patients underwent lymphadenectomy in the foreseen term from the end of the treatment with neoadjuvant therapy, except for patients who underwent the technique of Sentinel lymph node with negative result before the start of the study treatment. Clinical lymph node involvement were collected in the CRF. Behind the lymphadenectomy, the rate of patients with affected lymph nodes, regardless of the type of response in the breast. To help find out if the cancer has spread outside the breast, one or more of the lymph nodes in the axilla (axillary lymph nodes) are removed for examination under a microscope. This is an important part of the determination of the stage. When the lymph nodes have cancer cells, there is a greater chance that the cancer cells have spread to other parts of the body. Decisions about treatment will depend on whether there is cancer in the lymph nodes. | Up to 24 weeks |
| Terrassa |
| Barcelona |
| 08221 |
| Spain |
| Onkologikoa | Donostia / San Sebastian | Gipuzkoa | 20014 | Spain |
| Complejo Hospitalario Universitario A Coruña | A Coruña | 15006 | Spain |
| Centro Oncológico Regional de Galicia | A Coruña | 15009 | Spain |
| Hospital General de Alicante | Alicante | 03010 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitario Reina SofÃa | Córdoba | 14004 | Spain |
| Complejo Hospitalario de Jaén | Jaén | 23007 | Spain |
| Hospital de la Princesa | Madrid | 28006 | Spain |
| Hospital ClÃnico Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital ClÃnico Universitario de Valencia | Valencia | 46010 | Spain |
| Result |
| Alba E, Calvo L, Albanell J, De la Haba JR, Arcusa Lanza A, Chacon JI, Sanchez-Rovira P, Plazaola A, Lopez Garcia-Asenjo JA, Bermejo B, Carrasco E, Lluch A; GEICAM. Chemotherapy (CT) and hormonotherapy (HT) as neoadjuvant treatment in luminal breast cancer patients: results from the GEICAM/2006-03, a multicenter, randomized, phase-II study. Ann Oncol. 2012 Dec;23(12):3069-3074. doi: 10.1093/annonc/mds132. Epub 2012 Jun 6. |
| 25101563 | Result | Prat A, Lluch A, Albanell J, Barry WT, Fan C, Chacon JI, Parker JS, Calvo L, Plazaola A, Arcusa A, Segui-Palmer MA, Burgues O, Ribelles N, Rodriguez-Lescure A, Guerrero A, Ruiz-Borrego M, Munarriz B, Lopez JA, Adamo B, Cheang MC, Li Y, Hu Z, Gulley ML, Vidal MJ, Pitcher BN, Liu MC, Citron ML, Ellis MJ, Mardis E, Vickery T, Hudis CA, Winer EP, Carey LA, Caballero R, Carrasco E, Martin M, Perou CM, Alba E. Predicting response and survival in chemotherapy-treated triple-negative breast cancer. Br J Cancer. 2014 Oct 14;111(8):1532-41. doi: 10.1038/bjc.2014.444. Epub 2014 Aug 7. |
| 27903675 | Result | Prat A, Lluch A, Turnbull AK, Dunbier AK, Calvo L, Albanell J, de la Haba-Rodriguez J, Arcusa A, Chacon JI, Sanchez-Rovira P, Plazaola A, Munoz M, Pare L, Parker JS, Ribelles N, Jimenez B, Bin Aiderus AA, Caballero R, Adamo B, Dowsett M, Carrasco E, Martin M, Dixon JM, Perou CM, Alba E. A PAM50-Based Chemoendocrine Score for Hormone Receptor-Positive Breast Cancer with an Intermediate Risk of Relapse. Clin Cancer Res. 2017 Jun 15;23(12):3035-3044. doi: 10.1158/1078-0432.CCR-16-2092. Epub 2016 Nov 30. |
| 26786263 | Result | Alba E, Lluch A, Ribelles N, Anton-Torres A, Sanchez-Rovira P, Albanell J, Calvo L, Garcia-Asenjo JA, Palacios J, Chacon JI, Ruiz A, De la Haba-Rodriguez J, Segui-Palmer MA, Cirauqui B, Margeli M, Plazaola A, Barnadas A, Casas M, Caballero R, Carrasco E, Rojo F. High Proliferation Predicts Pathological Complete Response to Neoadjuvant Chemotherapy in Early Breast Cancer. Oncologist. 2016 Feb;21(2):150-5. doi: 10.1634/theoncologist.2015-0312. Epub 2016 Jan 19. |
| 29608913 | Result | Chin SF, Santonja A, Grzelak M, Ahn S, Sammut SJ, Clifford H, Rueda OM, Pugh M, Goldgraben MA, Bardwell HA, Cho EY, Provenzano E, Rojo F, Alba E, Caldas C. Shallow whole genome sequencing for robust copy number profiling of formalin-fixed paraffin-embedded breast cancers. Exp Mol Pathol. 2018 Jun;104(3):161-169. doi: 10.1016/j.yexmp.2018.03.006. Epub 2018 Mar 31. |
| 29899867 | Result | Santonja A, Sanchez-Munoz A, Lluch A, Chica-Parrado MR, Albanell J, Chacon JI, Antolin S, Jerez JM, de la Haba J, de Luque V, Fernandez-De Sousa CE, Vicioso L, Plata Y, Ramirez-Tortosa CL, Alvarez M, Llacer C, Zarcos-Pedrinaci I, Carrasco E, Caballero R, Martin M, Alba E. Triple negative breast cancer subtypes and pathologic complete response rate to neoadjuvant chemotherapy. Oncotarget. 2018 May 29;9(41):26406-26416. doi: 10.18632/oncotarget.25413. eCollection 2018 May 29. |
| 35223459 | Result | Ocana A, Chacon JI, Calvo L, Anton A, Mansutti M, Albanell J, Martinez MT, Lahuerta A, Bisagni G, Bermejo B, Semiglazov V, Thill M, Chan A, Morales S, Herranz J, Tusquets I, Chiesa M, Caballero R, Valagussa P, Bianchini G, Alba E, Gianni L. Derived Neutrophil-to-Lymphocyte Ratio Predicts Pathological Complete Response to Neoadjuvant Chemotherapy in Breast Cancer. Front Oncol. 2022 Feb 11;11:827625. doi: 10.3389/fonc.2021.827625. eCollection 2021. |
Postmenopausal patients: exemestane x 6 months Premenopausal patients: goserelin x 6 months + exemestane x 6 months |
| FG002 | Group 2 (Basal) Standard Treatment | Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles. |
| FG003 | Group 2 (Basal) Selective Treatment | Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (Luminal A) Standard Treatment | Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles. |
| BG001 | Group 1 (Luminal A) Selective Treatment | Postmenopausal patients: exemestane x 6 months Premenopausal patients: goserelin x 6 months + exemestane x 6 months |
| BG002 | Group 2 (Basal) Standard Treatment | Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles. |
| BG003 | Group 2 (Basal) Selective Treatment | Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Menopausal status | Count of Participants | Participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) status | Measure Description: ECOG score runs from 0 to 5, with 0 denoting perfect health and 5 death. 0 - Asymptomatic
| Count of Participants | Participants |
| |||||||||||||||
| Histologic type | Count of Participants | Participants |
| ||||||||||||||||
| Histological grade | Cancer cells are given a Grade (G) when they are removed from the breast and checked under a microscope. The G is based on how much the cancer cells look like normal cells. G1 or well differentiated (score 3, 4, or 5): cells are slower-growing, and look more like normal breast tissue. G2 or moderately differentiated (score 6, 7): cells are growing at a speed of and look like cells somewhere between G1 and 3. G3 or poorly differentiated (score 8, 9): cells look very different from normal and will probably grow and spread faster. | Count of Participants | Participants |
| |||||||||||||||
| Tumor size | Tumor (T) size describes the size of the tumour. Larger T is associated with inferior survival. TX: can't be assessed. Tis: ductal carcinoma in situ. T1: tumour is 2 centimetres (cm) across or less. T1mi: tumour is 0.1cm across or less T1a: tumour >0.1 cm but <0.5 cm T1b: tumour >0.5 cm but <1 cm T1c: tumour >1 cm but <2 cm T2: tumour >2 cm but <5 cm across. T3: tumour >5 cm across. T4a: tumour has spread into the chest wall T4b: tumour has spread into the skin and the breast might be swollen T4c: tumour has spread to both the skin and the chest wall T4d: inflammatory carcinoma | Count of Participants | Participants |
| |||||||||||||||
| Nodal status | Node (N) describes whether the cancer has spread to the Lymph Nodes (LN). Prognosis is better when cancer has not spread to the LN. The more LN that contain cancer, the poorer prognosis tends to be. NX: LN can't be assessed N0: no Cancer Cells (CC) N1: CC in the LN in the armpit but the nodes are not stuck to surrounding tissues. N2a: CC in the LN in the armpit, which are stuck to each other and to other structures. N2b: CC in the LN behind the breast bone. N3a: CC in LN below the collarbone. N3b: CC in LN in the armpit and behind the breastbone. N3c: CC in LN above the collarbone. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pathological Response for Basal Group 2 | This primary outcome only applies for the basal group 2 as per protocol. The pathological response in luminal group 1 was not pre-specified even as a Secondary Outcome. Pathological response was assessed after surgery, according to the Miller & Payne criteria, which stratifies the responses based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in breast and axilla. Grades 1-4 are categorised as a partial pathological response (pPR) and grade 5 was a complete pathological response (cPR). | For Group 2 (Basal) selective treatment: there was one patient who did not receive treatment, because of this is not included on the final analysis. | Posted | Count of Participants | Participants | Up to 24 weeks |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Clinical Response Rate | Clinical Response Rate was measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria for target lesions before surgery: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | For Group 2 (Basal) selective treatment: there was one patient who did not receive treatment, because of this is not included on the final analysis. | Posted | Count of Participants | Participants | Up to week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Breast Conservative Surgery Rate | All patients will undergo surgery within the expected period from the end of treatment with neoadjuvant therapy. The chosen surgical option will be collected in the Case Report Form (CRF) before starting the neoadjuvant treatment, depending on the characteristics Clinics of the patient at that time (conservative surgery or mastectomy). This information will be compared with definitive surgery, to analyze whether neoadjuvant treatment has contributed to increase the rate of conservative surgery. | For Group 2 (Basal) selective treatment: there was one patient who did not receive treatment, because of this is not included on the final analysis. | Posted | Count of Participants | Participants | Up to 24 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Axillary Node Status at the Time of Surgery | All the patients underwent lymphadenectomy in the foreseen term from the end of the treatment with neoadjuvant therapy, except for patients who underwent the technique of Sentinel lymph node with negative result before the start of the study treatment. Clinical lymph node involvement were collected in the CRF. Behind the lymphadenectomy, the rate of patients with affected lymph nodes, regardless of the type of response in the breast. To help find out if the cancer has spread outside the breast, one or more of the lymph nodes in the axilla (axillary lymph nodes) are removed for examination under a microscope. This is an important part of the determination of the stage. When the lymph nodes have cancer cells, there is a greater chance that the cancer cells have spread to other parts of the body. Decisions about treatment will depend on whether there is cancer in the lymph nodes. | For Group 2 (Basal) selective treatment: there was one patient who did not receive treatment, because of this is not included on the final analysis. | Posted | Count of Participants | Participants | Up to 24 weeks |
|
Through study treatment up to surgery, an average of 21 weeks
For Group 2 (Basal) selective treatment: there was one patient who did not receive treatment, because of this is not included on the final analysis.
For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.
For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 (Luminal A) Standard Treatment | Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles. | 0 | 45 | 5 | 45 | 45 | 45 |
| EG001 | Group 1 (Luminal A) Selective Treatment | Postmenopausal patients: exemestane x 6 months Premenopausal patients: goserelin x 6 months + exemestane x 6 months | 0 | 46 | 0 | 46 | 46 | 46 |
| EG002 | Group 2 (Basal) Standard Treatment | Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles. | 0 | 46 | 16 | 46 | 46 | 46 |
| EG003 | Group 2 (Basal) Selective Treatment | Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles. | 0 | 47 | 9 | 47 | 47 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Infections and infestations | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| Pancreatitis | Hepatobiliary disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Acute |
|
| Infection pulmonary/ Upper airway NOS | Infections and infestations | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 2 |
|
| Febrile neutropenia | Infections and infestations | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 4 |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 4 |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| Infection - Port a cath infection | Infections and infestations | CTCAE-NC version 3.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| Infection - Lung (pneumonia) | Infections and infestations | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| Infection - septic shock | Infections and infestations | CTCAE-NC version 3.0 | Non-systematic Assessment |
| |
| Mucositis/stomatitis and Vomiting | Gastrointestinal disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Mucositis grade 2, Vomiting grade 3 |
|
| Diabetes decompensation | Endocrine disorders | CTCAE-NC version 3.0 | Non-systematic Assessment |
| |
| Growth and abcessification of the tumor and cellulitis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE-NC version 3.0 | Non-systematic Assessment |
| |
| Infection with unknown ANC - Cellulitis | Infections and infestations | CTCAE-NC version 3.0 | Non-systematic Assessment |
| |
| Surgical intervention at left upper extremity | Investigations | CTCAE-NC version 3.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 4 |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 4 |
|
| Fatigue | General disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| Mucositis/stomatitis | Gastrointestinal disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| Febrile neutropenia | Infections and infestations | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| ALT, SGPT | Metabolism and nutrition disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| GGT | Metabolism and nutrition disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| GGT | Metabolism and nutrition disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 4 |
|
| Irregular menses | Reproductive system and breast disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| Febrile neutropenia | Infections and infestations | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 4 |
|
| Hypersensitivity | Immune system disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 4 |
|
| Platelets | Blood and lymphatic system disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 4 |
|
| Nausea | Gastrointestinal disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| Vomiting | Gastrointestinal disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| Infection | Infections and infestations | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 3 |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 1 |
|
| Hair loss/alopecia | Skin and subcutaneous tissue disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 2 |
|
| Hot flashes/flushes | Endocrine disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 1 |
|
| ALT, SGPT | Metabolism and nutrition disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 1 |
|
| Fatigue | General disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 1 |
|
| Headache | Nervous system disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 1 |
|
| Dizziness | General disorders | CTCAE-NC version 3.0 | Non-systematic Assessment | Grade 1 |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scientific Director / Medical Lead / Project Manager | Spanish Breast Cancer Research Group | +34916592870 | geicam@geicam.org |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015251 | Epirubicin |
| D003520 | Cyclophosphamide |
| D000077143 | Docetaxel |
| C056516 | exemestane |
| D017273 | Goserelin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| 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 |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Male |
|
| Postmenopausal |
|
| ECOG 1 |
|
| ECOG Unknown |
|
| Lobular |
|
| Other |
|
| Grade 2 |
|
| Grade 3 |
|
| T2 |
|
| T3 |
|
| T4 |
|
| N1 |
|
| N2 |
|
| Grade 3 |
|
| Grade 2 |
|
| Grade 1 |
|
| Not available |
|
| OG003 | Group 2 (Basal) Selective Treatment | Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles. |
|
|
Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.
| OG003 | Group 2 (Basal) Selective Treatment | Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles. |
|
|
Postmenopausal patients: exemestane x 6 months Premenopausal patients: goserelin x 6 months + exemestane x 6 months
| OG002 | Group 2 (Basal) Standard Treatment | Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles. |
| OG003 | Group 2 (Basal) Selective Treatment | Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles. |
|
|