A Phase 2 interventional study of Second line chemotherapy and trastuzumab [Herceptin] in Breast Cancer, sponsored by Hoffmann-La Roche. Completed at 30 sites in 8 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-21.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
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 (6mg/kg iv infusion every 3 weeks) while receiving second-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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 114 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 87 are open to participants now.
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Drug: Second line chemotherapy · Drug: trastuzumab [Herceptin]
Drug: Second line chemotherapy
As prescribed
6mg/kg iv every 3 weeks
Median Time to Disease Progression
Time to disease progression (TTP) in days was defined as the time from enrollment to objective disease progression (all categories other than objective disease progression was set to be censored including death before progression). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Tumor assessments were performed using computer tomography or magnetic resonance imaging. TTP as assessed by investigator, along with a recalculation done by computer algorithm is presented below. Median time was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
Time frame: Up to 5 years
Objective Response Rate
Objective response rate (ORR) is defined as the percentage of participants with tumor shrinkage of a predefined amount. It is a combination of complete response (CR) and partial response (PR) and was assessed according to the RECIST criteria 1.0. Complete response refers to the disappearance of all target lesions and all non-target non-measurable lesions. Partial Response refers to an at least 30 percent decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter. Objective response rate was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
Time frame: Up to 5 years
Clinical Benefit Rate
Clinical benefit rate (CBR) was defined as the percentage of participants taking a benefit from the treatments. CBR includes 1) Complete response (CR): disappearance of all target lesions and all non-target non-measurable lesions 2) Partial response (PR) : \>=30% decrease in the sum of the longest diameter of target lesions and 3) Stable disease (SD): non-PR and non-progressive disease. It was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by CT or MRI by the investigator. CBR was also assessed by computer. Clinical benefit rate was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
Time frame: Up to 5 years
Median Time to Treatment Failure
Time to treatment failure is defined as a composite endpoint measuring time (number of days) from enrollment to discontinuation of treatment or change in treatment for any reason, including disease progression, treatment toxicity and death. Median time to treatment failure was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
Time frame: Up to 5 years
Overall Survival
Overall Survival is defined as the time (number of days) between enrollment and the date of death due to any cause. Overall survival was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
Time frame: Up to 5 years
Number of Participants With Any Adverse Events and Serious Adverse Events
An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Time frame: Up to 5 years
Biochemistry Safety Laboratory Parameters: Mean Serum Glutamic Oxaloacetic Transaminase, Serum Glutamic-pyruvic Transaminase and Alkali Phosphatase Levels
Participants in the study were evaluated for the serum glutamic oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkali phosphatase (ALP) at Visit 1 and final study assessments (Up to 5 years). Serum glutamic oxaloacetic transaminase, Serum glutamic-pyruvic transaminase and Alkali Phosphatase levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
Time frame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years)
Biochemistry Safety Laboratory Parameters: Mean Total Bilirubin and Serum Creatinine Levels
Participants in the study were evaluated for the total bilirubin and serum creatinine. Total Bilirubin and serum creatinine levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
Time frame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years)
Biochemistry Safety Laboratory Parameters: Mean Albumin Levels
Participants in the study were evaluated for the albumin at Visit 1 and Final study assessments. Albumin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
Time frame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years)
Biochemistry Safety Laboratory Parameters: Mean Urea, Sodium and Potassium Levels
Participants in the study were evaluated for the biochemical safety laboratory parameters urea, sodium and potassium. Urea, sodium and potassium levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
Time frame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years)
Hematology Safety Laboratory Parameters: Mean Hemoglobin Levels
Participants in the study were evaluated for the Hemoglobin up to 5 years. Hemoglobin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
Time frame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)
Hematology Safety Laboratory Parameters: Mean Total Leukocytes Counts
Participants in the study were evaluated for the total leukocytes up to 5 years. Total leukocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
Time frame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)
Hematology Safety Laboratory Parameters: Percent of Differential for Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes Counts
Participants in the study were evaluated for the Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes at Visit 1 and final study assessments. Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
Time frame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)
Hematology Safety Laboratory Parameter: Mean Platelets Counts
Participants in the study were evaluated for the platelets at Visit 1 and final study assessments. Platelet counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
Time frame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)
Mean Left Ventricular Ejection Fraction
Left ventricular ejection fraction (LVEF) is a measure of the percent of blood ejected from the ventricle in one heartbeat. It is a measure of cardiac function and was assessed by echocardiogram or multigated angiogram at Visit 0 \[Screening period (6 weeks prior to enrollment)\] and final study assessments (Up to 5 years).
Time frame: Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years).
A total of 114 participants were enrolled in this study conducted from March 2007 to August 2011 at 30 centers in 8 countries.
| Milestone | Trastuzumab + 2nd Line Chemotherapy | Only Chemotherapy |
|---|---|---|
| Started | 93 | 16 |
| Completed | 10 | 1 |
| Not completed | 83 | 15 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Progression of the disease | 73 | 8 |
| Withdrew: Refused treatment/did not cooperate | 4 | 1 |
| Withdrew: Investigator decision | 3 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Missing | 0 | 5 |
Time to disease progression (TTP) in days was defined as the time from enrollment to objective disease progression (all categories other than objective disease progression was set to be censored including death before progression). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Tumor assessments were performed using computer tomography or magnetic resonance imaging. TTP as assessed by investigator, along with a recalculation done by computer algorithm is presented below. Median time was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
| Days | Trastuzumab + 2nd Line Chemotherapy |
|---|---|
| By Computer (n = 65) | 171 (136 to 322) |
| By Investigator (n = 73) | 171 (136 to 265) |
Objective response rate (ORR) is defined as the percentage of participants with tumor shrinkage of a predefined amount. It is a combination of complete response (CR) and partial response (PR) and was assessed according to the RECIST criteria 1.0. Complete response refers to the disappearance of all target lesions and all non-target non-measurable lesions. Partial Response refers to an at least 30 percent decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter. Objective response rate was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
| Percentage of participants | Trastuzumab + 2nd Line Chemotherapy |
|---|---|
| By Investigator (n= 87) | 43.7 (33.1 to 54.8) |
| By computer (n=87) | 43.7 (33.1 to 54.8) |
Clinical benefit rate (CBR) was defined as the percentage of participants taking a benefit from the treatments. CBR includes 1) Complete response (CR): disappearance of all target lesions and all non-target non-measurable lesions 2) Partial response (PR) : \>=30% decrease in the sum of the longest diameter of target lesions and 3) Stable disease (SD): non-PR and non-progressive disease. It was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by CT or MRI by the investigator. CBR was also assessed by computer. Clinical benefit rate was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
| Percentage of participants | Trastuzumab + 2nd Line Chemotherapy |
|---|---|
| By Computer (n = 87) | 75.9 (65.5 to 84.4) |
| By Investigator (n = 87) | 72.4 (61.8 to 81.5) |
Time to treatment failure is defined as a composite endpoint measuring time (number of days) from enrollment to discontinuation of treatment or change in treatment for any reason, including disease progression, treatment toxicity and death. Median time to treatment failure was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
| Days | Trastuzumab + 2nd Line Chemotherapy |
|---|---|
| Median Time to Treatment Failure | 154 (131 to 238) |
Overall Survival is defined as the time (number of days) between enrollment and the date of death due to any cause. Overall survival was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
| Days | Trastuzumab + 2nd Line Chemotherapy |
|---|---|
| Overall Survival | 717 (589 to 1057) |
An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
| Number of participants | Trastuzumab + 2nd Line Chemotherapy | Only Chemotherapy |
|---|---|---|
| Number of participants with any AE | 84 | 10 |
| Number of participants with any SAE | 20 | 2 |
Participants in the study were evaluated for the serum glutamic oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkali phosphatase (ALP) at Visit 1 and final study assessments (Up to 5 years). Serum glutamic oxaloacetic transaminase, Serum glutamic-pyruvic transaminase and Alkali Phosphatase levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
| Units per liter | Trastuzumab + 2nd Line Chemotherapy |
|---|---|
| SGOT, Visit 1, (n = 93) | 31.46 ± 29.78 |
| SGOT, Final study assessments, (n = 62) | 36.16 ± 34.91 |
| SGPT, Visit 1, (n = 93) | 25.86 ± 20.55 |
| SGPT, Final study assessments, (n = 61) | 28.19 ± 16.92 |
| ALP, Visit 1, (n = 93) | 202.30 ± 149.98 |
| ALP, Final study assessments, (n = 62) | 193.49 ± 148.11 |
Participants in the study were evaluated for the total bilirubin and serum creatinine. Total Bilirubin and serum creatinine levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
| Micromole/liter | Trastuzumab + 2nd Line Chemotherapy |
|---|---|
| Total bilirubin, Visit 1, (n = 93) | 13.50 ± 42.74 |
| Total bilirubin, Final study assessments(n = 60) | 19.16 ± 36.77 |
| Serum creatinine, Visit 1, (n = 92) | 81.18 ± 61.75 |
| Serum creatinine,Final study assessment (n = 63) | 82.53 ± 70.86 |
Participants in the study were evaluated for the albumin at Visit 1 and Final study assessments. Albumin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
| gram per liter | Trastuzumab + 2nd Line Chemotherapy |
|---|---|
| Albumin, Visit 1, (n = 84) | 43.99 ± 3.29 |
| Albumin, Final study assessments, (n = 54) | 41.07 ± 6.96 |
Participants in the study were evaluated for the biochemical safety laboratory parameters urea, sodium and potassium. Urea, sodium and potassium levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
| Millimole per liter | Trastuzumab + 2nd Line Chemotherapy |
|---|---|
| Urea, Visit 1, (n = 92) | 6.33 ± 3.07 |
| Urea, Final study assessments, (n = 63) | 6.92 ± 4.93 |
| Sodium, Visit 1, (n = 92) | 140.58 ± 3.34 |
| Sodium, Final study assessments, (n = 61) | 139.16 ± 3.71 |
| Potassium, Visit 1, (n = 91) | 4.40 ± 0.45 |
| Potassium, Final study assessments, (n = 61) | 4.22 ± 0.40 |
Participants in the study were evaluated for the Hemoglobin up to 5 years. Hemoglobin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
| grams per deciliter | Trastuzumab + 2nd Line Chemotherapy |
|---|---|
| Hemoglobin, Visit 1, (n = 93) | 12.67 ± 2.03 |
| Hemoglobin, Final study assessments, (n = 67) | 11.00 ± 3.57 |
Participants in the study were evaluated for the total leukocytes up to 5 years. Total leukocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
| 10^9 leukocytes/L | Trastuzumab + 2nd Line Chemotherapy |
|---|---|
| Total Leukocytes, Visit 1, (n = 92) | 8.00 ± 8.60 |
| Total Leukocytes, Final study assessment (n =67) | 7.53 ± 6.88 |
Participants in the study were evaluated for the Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes at Visit 1 and final study assessments. Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
| percent of differential | Trastuzumab + 2nd Line Chemotherapy |
|---|---|
| Neutrophils, Visit 1, (n = 93) | 64.89 ± 10.66 |
| Neutrophils, Final study assessments, (n = 64) | 62.22 ± 14.80 |
| Basophils, Visit 1, (n = 86) | 0.38 ± 0.33 |
| Basophils, Final study assessments, (n = 59) | 1.28 ± 6.34 |
| Eosinophils, Visit 1, (n = 88) | 2.36 ± 2.15 |
| Eosinophils, Final study assessments, (n = 61) | 2.50 ± 3.56 |
| Lymphocytes, Visit 1, (n = 93) | 26.34 ± 9.37 |
| Lymphocytes, Final study assessments, (n = 64) | 26.48 ± 12.85 |
| Monocytes, Visit 1, (n = 89) | 5.92 ± 2.22 |
| Monocytes, Final study assessments, (n = 59) | 7.25 ± 3.56 |
Participants in the study were evaluated for the platelets at Visit 1 and final study assessments. Platelet counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
| Number of cells x 10^9/L | Trastuzumab + 2nd Line Chemotherapy |
|---|---|
| Platelets, Visit 1, (n = 93) | 263.14 ± 63.91 |
| Platelets, Final study assessments, (n = 67) | 256.64 ± 78.64 |
Left ventricular ejection fraction (LVEF) is a measure of the percent of blood ejected from the ventricle in one heartbeat. It is a measure of cardiac function and was assessed by echocardiogram or multigated angiogram at Visit 0 \[Screening period (6 weeks prior to enrollment)\] and final study assessments (Up to 5 years).
| percent of blood pumped from LV chamber] | Trastuzumab + 2nd Line Chemotherapy | Only Chemotherapy |
|---|---|---|
| Visit 0 (n = 92, 16) | 63.3 ± 6.8 | 62.6 ± 6.9 |
| Final study assessment (n= 53, 5) | 61.2 ± 7.4 | 68.6 ± 5.9 |
Collected over Up to 5 years. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Trastuzumab + 2nd Line Chemotherapy | — | 20/93 (21.5%) | 81/93 (87.1%) |
| Only Chemotherapy | — | 2/16 (12.5%) | 9/16 (56.3%) |
| Event | Trastuzumab + 2nd Line Chemotherapy | Only Chemotherapy |
|---|---|---|
| Angina pectorisCardiac disorders | 0/93 | 1/16 |
| DeathGeneral disorders | 0/93 | 1/16 |
| PneumoniaInfections and infestations | 5/93 | 0/16 |
| DiarrhoeaGastrointestinal disorders | 3/93 | 0/16 |
| LeukopeniaBlood and lymphatic system disorders | 2/93 | 0/16 |
| Cardiopulmonary failureCardiac disorders | 2/93 | 0/16 |
| GranulocytosisBlood and lymphatic system disorders | 1/93 | 0/16 |
| Atrial fibrillationCardiac disorders | 1/93 | 0/16 |
| Retinal detachmentEye disorders | 1/93 | 0/16 |
| NauseaGastrointestinal disorders | 1/93 | 0/16 |
| Event | Trastuzumab + 2nd Line Chemotherapy | Only Chemotherapy |
|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 80/93 | 1/16 |
| LeukopeniaBlood and lymphatic system disorders | 76/93 | 3/16 |
| NauseaGastrointestinal disorders | 53/93 | 0/16 |
| DiarrhoeaGastrointestinal disorders | 52/93 | 1/16 |
| FatigueGeneral disorders | 30/93 | 7/16 |
| Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders | 37/93 | 4/16 |
| AnemiaBlood and lymphatic system disorders | 25/93 | 5/16 |
| Oedema peripheralGeneral disorders | 8/93 | 4/16 |
| VomitingGastrointestinal disorders | 21/93 | 1/16 |
| HypertensionVascular disorders | 19/93 | 1/16 |
The Safety Population included all participants who entered the trial and received at least one dose of trial medication.
| Age, Continuous(years) | Trastuzumab + 2nd Line Chemotherapy | Only Chemotherapy | Total |
|---|---|---|---|
| Mean | 55.4 ± 12.8 | 56.3 ± 10.2 | 55.5 ± 12.4 |
| Sex: Female, Male(Participants) | Trastuzumab + 2nd Line Chemotherapy | Only Chemotherapy | Total |
|---|---|---|---|
| Female | 93 | 16 | 109 |
| Male | 0 | 0 | 0 |
The record gives a start of Mar 2007, a primary completion of Aug 2011 and a completion of Aug 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2016, 4 years 10 months after primary completion.
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Studies of the drug tested here: Trastuzumab