Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks.
Sample size calculation will be done by means of Simon's method in 2 stages for phase II studies and will be based on the principal aim of the study (evaluation of the rate of objective response).
The hypothesis brings over of the efficiency of the treatment it will be accepted if a rate of objective response of at least 55 % is obtained, rejecting the efficiency of the treatment when the rate of response targets be lower than 35 %. In this case, considering an alpha error of 0.05 and 80 % power, 14 patients will be included in the first stage; the study would continue if more than 5 objective responses were found. The total number of patients to including in the study would be 44. The results will be significant if they find at least 20 objective responses.
Assuming a drop-out rate of 10 %, the total number of patients needed is 49 patients.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caelyx,Cyclophosphamide,Trastuzumab | Other | Caelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Doxorubicin | Drug |
|
| |
| Cyclophosphamide |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is the sum of the Complete Responses (CR) and Partial Responses (PR) according to the RECIST criteria, experienced for each patient during treatment (recorded from the start of the treatment until disease progression). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan (computed tomography) or MRI (magnetic resonance imaging): 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 Rate (ORR) = CR + PR. | Up to cycle 6 (24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (TTP) | TTP was defined as the time elapsed from first treatment until clinical evidence of disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | Through study treatment, and follow up period, assessed up to 88 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Hospital ClÃnico Universitario San Carlos | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Fundación Hospital Alcorcón |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21421542 | Result | Martin M, Sanchez-Rovira P, Munoz M, Baena-Canada JM, Mel JR, Margeli M, Ramos M, Martinez E, Garcia-Saenz JA, Casado A, Jaen AM, Gonzalez-Farre X, Escudero MJ, Rodriguez-Martin C, Carrasco E; GEICAM. Pegylated liposomal doxorubicin in combination with cyclophosphamide and trastuzumab in HER2-positive metastatic breast cancer patients: efficacy and cardiac safety from the GEICAM/2004-05 study. Ann Oncol. 2011 Dec;22(12):2591-2596. doi: 10.1093/annonc/mdr024. Epub 2011 Mar 17. |
| Label | URL |
|---|---|
| Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group | View source |
Not provided
Not provided
Between February 2006 and June 2008, 49 patients were enrolled at 12 Spanish sites. One patient never received treatment due to early death from progressive disease and was not included in this analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab | Liposomal Doxorubicin 50 mg/m2 every 4 weeks for six cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for six cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg) Liposomal Doxorubicin Cyclophosphamide Trastuzumab |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Between February 2006 and June 2008, 49 patients were enrolled at 12 Spanish sites. One patient never received treatment due to early death from progressive disease and was not included in this analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab | Liposomal Doxorubicin 50 mg/m2 every 4 weeks for six cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for six cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg) Liposomal Doxorubicin Cyclophosphamide Trastuzumab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Patient included by error at 78 years. |
| 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 | Objective Response Rate (ORR) | ORR is the sum of the Complete Responses (CR) and Partial Responses (PR) according to the RECIST criteria, experienced for each patient during treatment (recorded from the start of the treatment until disease progression). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan (computed tomography) or MRI (magnetic resonance imaging): 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 Rate (ORR) = CR + PR. | 49 patients included but 1 is not considered due to not receive any treatment and died before start | Posted | Count of Participants | Participants | Up to cycle 6 (24 weeks) |
|
Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
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 | Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab | Liposomal Doxorubicin 50 mg/m2 every 4 weeks for six cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for six cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular ischemia | Nervous system disorders | NCI-CTC-AE v. 3 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytes | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 4 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scientific Director / Medical Lead / Project Manager | Spanish Breast Cancer Research Group | +34 916 592 870 | geicam@geicam.org |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
| D003520 | Cyclophosphamide |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| Trastuzumab | Drug |
|
|
| Time to Treatment Failure (TTF) | TTF was defined as the time elapsed from first treatment until patient discontinuation due to toxicity, disease progression, death or withdrawal of consent for any reason, whichever occurred first. | Through study treatment, and follow up period, assessed up to 88 weeks |
| Response Duration | Response duration was defined as the time elapsed from the first evidence of tumor response (Complete response or Partial Response) until clinical evidence of disease progression or death occurred. | Through study treatment, and follow up period, assessed up to 88 weeks |
| Overall Survival (OS) | OS was defined as the time elapsed from first treatment until death from any cause. | Through study treatment, and follow up period, assessed up to 88 weeks |
| Alcorcón |
| Madrid |
| 28922 |
| Spain |
| Hospital Juan Canalejo | A Coruña | 15006 | Spain |
| Centro Oncológico Regional de Galicia | A Coruña | 15009 | Spain |
| Hospital Clinic i Provincial | Barcelona | 08036 | Spain |
| Hospital Puerta del Mar | Cadiz | 11009 | Spain |
| Hospital Provincial de Castellón | Castelló | 12002 | Spain |
| Complejo Hospitalario de Jaen | Jaén | 23007 | Spain |
| Hospital Xeral Calde de Lugo | Lugo | 27004 | Spain |
| Hospital Universitario Doce de Octubre | Madrid | 28021 | Spain |
| Hospital ClÃnico Universitario San Carlos | Madrid | 28040 | Spain |
| Hospital Nuestra Señora de Candelaria | Santa Cruz de Tenerife | 38010 | Spain |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Mistake |
|
| Median |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Eastern Cooperative Oncology Group (ECOG) | Measure Description: ECOG score runs from 0 to 5, with 0 denoting perfect health and 5 death. 0 - Asymptomatic
| Count of Participants | Participants |
|
| Menopausal Status | Count of Participants | Participants |
|
| Hormonal receptor status | A cancer is called hormonal receptor positive if it has receptors for progesterone or estrogen. This suggests that the cancer cells, like normal breast cells, may receive signals from progesterone or estrogen that could promote their growth. If the cancer is hormone-receptor-negative (no receptors are present), then hormonal therapy is unlikely to work. | Count of Participants | Participants |
|
| Disease stage at diagnosis | TNM staging system: Stage (S) 0: noninvasive ductal carcinoma in situ S IA: tumor small, invasive S IB: spread to the lymph nodes (LN) and >0.2 mm but <2 mm. S IIA:
S IIB:
S IIIC: tumor that has spread to 10 or more LN. S IV: tumor has spread to other organs | Count of Participants | Participants |
|
| Prior neo(adjuvant) chemotherapy | Count of Participants | Participants |
|
| Number of disease sites | Count of Participants | Participants |
|
|
|
| Secondary | Time to Progression (TTP) | TTP was defined as the time elapsed from first treatment until clinical evidence of disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | 49 patients included but 1 is not considered due to not receive any treatment and died before start | Posted | Median | 95% Confidence Interval | Months | Through study treatment, and follow up period, assessed up to 88 weeks |
|
|
|
| Secondary | Time to Treatment Failure (TTF) | TTF was defined as the time elapsed from first treatment until patient discontinuation due to toxicity, disease progression, death or withdrawal of consent for any reason, whichever occurred first. | 49 patients included but 1 is not considered due to not receive any treatment and died before start | Posted | Median | 95% Confidence Interval | Months | Through study treatment, and follow up period, assessed up to 88 weeks |
|
|
|
| Secondary | Response Duration | Response duration was defined as the time elapsed from the first evidence of tumor response (Complete response or Partial Response) until clinical evidence of disease progression or death occurred. | Patients with Overall Response (see ORR objective) | Posted | Median | 95% Confidence Interval | Months | Through study treatment, and follow up period, assessed up to 88 weeks |
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the time elapsed from first treatment until death from any cause. | 49 patients included but 1 is not considered due to not receive any treatment and died before start | Posted | Median | 95% Confidence Interval | Months | Through study treatment, and follow up period, assessed up to 88 weeks |
|
|
|
| 2 |
| 48 |
| 16 |
| 48 |
| 48 |
| 48 |
| Febrile neutropenia grade 3 | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | Systematic Assessment |
|
| Hemorrhage CNS grade 5 | Nervous system disorders | NCI-CTC-AE v. 3 | Systematic Assessment |
|
| Infection with normal ANC (skin celluties grade 3) | Skin and subcutaneous tissue disorders | NCI-CTC-AE v. 3 | Systematic Assessment |
|
| Acute respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | NCI-CTC-AE v. 3 | Systematic Assessment |
|
| Catheter - related infection grade 3 | Infections and infestations | NCI-CTC-AE v. 3 | Systematic Assessment |
|
| Holocraneal cephalea | General disorders | NCI-CTC-AE v. 3 | Systematic Assessment |
|
| Neutropenia grade 3 | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | Systematic Assessment |
|
| Hemorrhage subarachnoid | Vascular disorders | NCI-CTC-AE v. 3 | Systematic Assessment |
|
| Hypersensibility reaction grade 3 | General disorders | NCI-CTC-AE v. 3 | Systematic Assessment |
|
| Palmoplantar erythrodysesthesia grade 3, stomatitis grade 3 | General disorders | NCI-CTC-AE v. 3 | Systematic Assessment |
|
| Progression disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI-CTC-AE v. 3 | Systematic Assessment |
|
| Neutropenia grade 4, fever grade 1, oral mucositis grade 3 | General disorders | NCI-CTC-AE v. 3 | Systematic Assessment |
|
|
| Neutrophils / Granulocytes | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 4 |
|
| Fatigue | General disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 4 |
|
| Mucositis / Stomatitis | Gastrointestinal disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 4 |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 4 |
|
| Pneumonitis/Pulmonary infiltrates | Reproductive system and breast disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 5 |
|
| Leukocytes | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 3 |
|
| Leukocytes | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 2 |
|
| Hemoglobin | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 2 |
|
| Rash: Hand-foot skin reaction | Skin and subcutaneous tissue disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 3 |
|
| Mucositis / Stomatitis | Gastrointestinal disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 3 |
|
| Lymphopenia | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 2 |
|
| Lymphopenia | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 3 |
|
| Neutrophils / Granulocytes | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 3 |
|
| Neutrophils / Granulocytes | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 2 |
|
| Left Ventricular systolic dysfunction | Cardiac disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 2 |
|
| Fatigue | General disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 2 |
|
| Fatigue | General disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 1 |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 2 |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 1 |
|
| Rash: Hand-foot skin reaction | Skin and subcutaneous tissue disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 2 |
|
| Rash: Hand-foot skin reaction | Skin and subcutaneous tissue disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 1 |
|
| Heartburn/dyspepsia | Gastrointestinal disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 2 |
|
| Hemoglobin | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 1 |
|
| Leukocytes | Blood and lymphatic system disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 1 |
|
| Left Ventricular diastolic dysfunction | Cardiac disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 1 |
|
| Fever | General disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 1 |
|
| Hair loss/alopecia | Skin and subcutaneous tissue disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 1 |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 1 |
|
| Anorexia | Gastrointestinal disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 1 |
|
| Mucositis / Stomatitis | Gastrointestinal disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 1 |
|
| Nausea | Gastrointestinal disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 1 |
|
| Infection with normal ANC or G1 or 2 neutrophils | Infections and infestations | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 2 |
|
| Alkaline phosphatase | Metabolism and nutrition disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 1 |
|
| ALT, SGPT | Metabolism and nutrition disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 1 |
|
| AST, SGOT | Metabolism and nutrition disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 1 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | NCI-CTC-AE v. 3 | Systematic Assessment | Grade 1 |
|
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |