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This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment (2mg/kg iv infusion weekly, or 6mg/kg iv infusion every 3 weeks) while receiving 2nd line chemotherapy of the investigator's choice. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy Alone | Active Comparator | Chemotherapy, schedule and dose at the investigator's discretion. |
|
| Chemotherapy, Trastuzumab | Experimental | Trastuzumab, at the investigator's discretion, either 2 milligrams per kilogram (mg/kg) intravenous (i.v.) every 7 days or 6 mg/kg i.v. every 3 weeks. Chemotherapy, schedule and dose at the investigator's discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trastuzumab | Drug | 2mg/kg i.v. weekly, or 6mg/kg i.v. every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) - Percentage of Participants With an Event | PFS was defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Participants were censored at the last tumour evaluation. | Baseline (BL) and every 8 weeks thereafter |
| Progression-Free Survival - Time to Event | The median time from randomization to PFS event. Participants were censored at the last tumour evaluation. | BL and every 8 weeks thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) - Percentage of Participants With an Event | OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the last contact date at which the participant was known to be alive. | BL and every 8 weeks thereafter |
| Overall Survival - Time to Event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avellino | 83100 | Italy | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy Alone | Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Chemotherapy | Drug | Schedule and dose at the investigator's discretion |
|
The median time from randomization to OS event. Participants were censored at the last contact date at which the participant was known to be alive. |
| BL and every 8 weeks thereafter |
| Percentage of Participants by Best Overall Response (BOR) | BOR was defined as the best objective response observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR): disappearance of all target lesions (TLs), with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). Partial response (PR): at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. Progressive disease (PD): at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | BL and every 8 weeks thereafter |
| Percentage of Participants With a Best Overall Response of CR or PR | BOR was defined as the best objective response observed during the treatment period according to RECIST version 1.1. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. PD: at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. SD: neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | BL and every 8 weeks thereafter |
| Brescia |
| 25123 |
| Italy |
| Candiolo | 10060 | Italy |
| Carrara | 54033 | Italy |
| Cona (Ferrara) | 44124 | Italy |
| Cosenza | 87100 | Italy |
| Crotone - Kr | 88900 | Italy |
| Fano | 61032 | Italy |
| Florence | 50139 | Italy |
| Frattaminore | 80026 | Italy |
| Genova | 16132 | Italy |
| Lecce | 73100 | Italy |
| Livorno | 57100 | Italy |
| Mantua | 46100 | Italy |
| Meldola | 47014 | Italy |
| Naples | 80131 | Italy |
| Nocera Inferiore | 84014 | Italy |
| Padova | 35128 | Italy |
| Palermo | 90127 | Italy |
| Pavia | 27100 | Italy |
| Perugia | 06122 | Italy |
| Pordenone | 33170 | Italy |
| Potenza | 85100 | Italy |
| Ragusa | 97100 | Italy |
| Reggio Calabria | 89100 | Italy |
| Rionero in Vulture | 85028 | Italy |
| Roma | 00128 | Italy |
| Roma | 00153 | Italy |
| Salerno | 84131 | Italy |
| San Giovanni Rotondo | 71013 | Italy |
| Sassari | 07100 | Italy |
| Sora | 03039 | Italy |
| Taormina | 98030 | Italy |
| Torino | 10125 | Italy |
| Udine | 33100 | Italy |
| FG001 |
| Chemotherapy Plus (+) Trastuzumab |
Participants received trastuzumab at either 2 milligrams per kilogram (mg/kg), intravenously (IV), every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population: all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy Alone | Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. |
| BG001 | Chemotherapy + Trastuzumab | Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death. |
| BG002 | 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 |
|
| 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 | Progression-Free Survival (PFS) - Percentage of Participants With an Event | PFS was defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Participants were censored at the last tumour evaluation. | ITT population | Posted | Number | percentage of participants | Baseline (BL) and every 8 weeks thereafter |
|
|
| |||||||||||||||||||||||||||||
| Primary | Progression-Free Survival - Time to Event | The median time from randomization to PFS event. Participants were censored at the last tumour evaluation. | ITT population | Posted | Median | 95% Confidence Interval | months | BL and every 8 weeks thereafter |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) - Percentage of Participants With an Event | OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the last contact date at which the participant was known to be alive. | ITT population | Posted | Number | percentage of participants | BL and every 8 weeks thereafter |
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival - Time to Event | The median time from randomization to OS event. Participants were censored at the last contact date at which the participant was known to be alive. | ITT population | Posted | Median | 95% Confidence Interval | months | BL and every 8 weeks thereafter |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants by Best Overall Response (BOR) | BOR was defined as the best objective response observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR): disappearance of all target lesions (TLs), with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). Partial response (PR): at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. Progressive disease (PD): at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | ITT population | Posted | Number | percentage of participants | BL and every 8 weeks thereafter |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Best Overall Response of CR or PR | BOR was defined as the best objective response observed during the treatment period according to RECIST version 1.1. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. PD: at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. SD: neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | BL and every 8 weeks thereafter |
|
Adverse events (AEs) were recorded throughout the study. Drug-related serious AEs (SAEs) were collected, regardless of the time elapsed from last study treatment administration, even if the study had been closed.
All randomized participants who received at least 1 dose of study treatment were included in the safety evaluation.
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 | Chemotherapy Alone | Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. | 4 | 26 | 26 | 26 | ||
| EG001 | Chemotherapy + Trastuzumab | Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death. | 1 | 28 | 26 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | SOURCE VOCAB NEEDED | Non-systematic Assessment |
| |
| General Malaise | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Gastric volvulus | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Acute renal failure | Renal and urinary disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Hospitalisation for intrapleuric chemotherapy and thoracentesis | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Liver-GOT,GPT | Hepatobiliary disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Other - unspecified | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Neuro device | Nervous system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Pain | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Cutanea SMP | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Vertigo syndrome | Nervous system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Scapular pain | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Dorsal spine pain | Musculoskeletal and connective tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Fever | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Liver-ALP | Hepatobiliary disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Pain - Spine | Musculoskeletal and connective tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Decline in mood | Psychiatric disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Allergy | Immune system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Plantar foot pain | Musculoskeletal and connective tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Exertional dyspnea | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Hand fissures | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Paresthesia - hand | Nervous system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Gingival | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Pelvic pain | Musculoskeletal and connective tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Memory deficit | Nervous system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Abdominal cramps | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Epigastric pain | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Sore throat | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Edema | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Urinary infection | Infections and infestations | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Right upper limb pain | Musculoskeletal and connective tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Cranial pain | Musculoskeletal and connective tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Paraesthesia hand and feet | Nervous system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Achy hands and feet | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Hypercholesterolemia | Investigations | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Bilateral mandibular pain | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Erythema hand and foot | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Liver-bilirubin | Hepatobiliary disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Diabetes | Metabolism and nutrition disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 | genentech@druginfo.com |
| 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 |
|---|---|
| D000068878 | Trastuzumab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| 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 |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death. |
|
|
|
|