A Phase 3 interventional study of bevacizumab [Avastin] and Docetaxel in Breast Cancer, sponsored by Hoffmann-La Roche. Completed at 90 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-28.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 424 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: bevacizumab [Avastin] · Drug: Docetaxel · Drug: Herceptin
Drug: Docetaxel · Drug: Herceptin
15mg/kg iv every 3 weeks
100mg/m2 iv every 3 weeks
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks
Progression Free Survival (PFS)
PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators' assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods.
Time frame: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Overall Survival (OS)
OS was defined as the time from randomization to the date of death, regardless of the cause of death. OS was estimated using Kaplan-Meier methods.
Time frame: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline
Best OR was assessed using RECIST v1.0 criteria. Participants were classified as responders if their best OR was either confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of the longest diameter \[LD\] of target lesions, taking as reference the baseline sum LD). Participants without any post-baseline assessments were regarded as non-responders. The 95% CI for the one sample binomial using Pearson-Clopper method.
Time frame: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Duration of Response (DR)
DR was defined as the time when response (CR or PR per RECIST v1.0) was first documented to the date of disease progression per RECIST v1.0 (unequivocal progression of existing non-target lesions) or death. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.
Time frame: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Time to Treatment Failure (TTF)
TTF was defined as the time between randomization and date of disease progression (per RECIST v1.0; unequivocal progression of existing non-target lesions), death, or withdrawal of treatment due to adverse events, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.
Time frame: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.
Time frame: Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])
Change From Baseline for FACT-G and FACT-B
FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.
Time frame: Baseline, Cycles 3, 5, 11, and post PD (14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])
| Milestone | Trastuzumab + Docetaxel | Trastuzumab + Bevacizumab + Docetaxel |
|---|---|---|
| Started | 208 | 216 |
| Received treatment | 206 | 215 |
| Completed | 0 | 0 |
| Not completed | 208 | 216 |
| Withdrew: Death | 78 | 81 |
| Withdrew: Lost to follow-up | 13 | 18 |
| Withdrew: Alive on treatment | 29 | 33 |
| Withdrew: Alive in follow-up | 88 | 84 |
PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators' assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods.
| months | Trastuzumab + Docetaxel | Trastuzumab + Bevacizumab + Docetaxel |
|---|---|---|
| Progression Free Survival (PFS) | 13.7 (11.4 to 16.3) | 16.5 (14.1 to 19.1) |
OS was defined as the time from randomization to the date of death, regardless of the cause of death. OS was estimated using Kaplan-Meier methods.
| months | Trastuzumab + Docetaxel | Trastuzumab + Bevacizumab + Docetaxel |
|---|---|---|
| Overall Survival (OS) | 38.3 (34.3 to NA) | 38.5 (32.1 to NA) |
Best OR was assessed using RECIST v1.0 criteria. Participants were classified as responders if their best OR was either confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of the longest diameter \[LD\] of target lesions, taking as reference the baseline sum LD). Participants without any post-baseline assessments were regarded as non-responders. The 95% CI for the one sample binomial using Pearson-Clopper method.
| percentage of participants | Trastuzumab + Docetaxel | Trastuzumab + Bevacizumab + Docetaxel |
|---|---|---|
| Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline | 69.9 (62.5 to 76.6) | 74.3 (67.4 to 80.5) |
DR was defined as the time when response (CR or PR per RECIST v1.0) was first documented to the date of disease progression per RECIST v1.0 (unequivocal progression of existing non-target lesions) or death. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.
| months | Trastuzumab + Docetaxel | Trastuzumab + Bevacizumab + Docetaxel |
|---|---|---|
| Duration of Response (DR) | 11.4 (9.1 to 13.2) | 14.6 (12.0 to 17.1) |
TTF was defined as the time between randomization and date of disease progression (per RECIST v1.0; unequivocal progression of existing non-target lesions), death, or withdrawal of treatment due to adverse events, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.
| months | Trastuzumab + Docetaxel | Trastuzumab + Bevacizumab + Docetaxel |
|---|---|---|
| Time to Treatment Failure (TTF) | 7.7 (6.3 to 8.6) | 9.8 (7.9 to 10.9) |
FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.
| units on a scale | Trastuzumab + Docetaxel | Trastuzumab + Bevacizumab + Docetaxel |
|---|---|---|
| Physical Well-Being: Baseline (n=173,189) | 21.20 ± 5.74 | 21.47 ± 5.07 |
| Social Well-Being: Baseline (n=173,189) | 20.59 ± 5.75 | 20.88 ± 5.77 |
| Emotional Well-Being: Baseline (n=173,189) | 14.95 ± 4.95 | 15.54 ± 4.44 |
| Functional Well-Being: Baseline (n=173,189) | 16.34 ± 5.83 | 16.36 ± 5.57 |
| Total FACT-G Score: Baseline (n=173,189) | 73.30 ± 16.60 | 74.49 ± 14.50 |
| Breast Specific: Baseline (n=173,189) | 21.67 ± 6.43 | 22.84 ± 5.85 |
| Total FACT-B Score: Baseline (n=173,189) | 94.97 ± 20.50 | 97.46 ± 17.71 |
| Trial Outcome Index: Baseline (n=173,189) | 59.54 ± 14.03 | 60.85 ± 12.61 |
| Physical Well-Being: Cycle 3 (n=145,173) | 20.19 ± 4.89 | 19.96 ± 5.05 |
| Social Well-Being: Cycle 3 (n=145,173) | 20.64 ± 5.32 | 21.19 ± 5.44 |
| Emotional Well-Being: Cycle 3 (n=145,173) | 16.47 ± 4.19 | 16.70 ± 4.36 |
| Functional Well-Being: Cycle 3 (n=145, 173) | 15.43 ± 5.33 | 16.20 ± 5.22 |
| Total FACT-G Score: Cycle 3 (n=145,173) | 72.94 ± 14.81 | 74.05 ± 14.35 |
| Breast Specific: Cycle 3 (n=145,173) | 22.29 ± 5.78 | 23.17 ± 5.34 |
| Total FACT-B Score: Cycle 3 (n=145,173) | 95.26 ± 18.52 | 97.23 ± 17.81 |
| Trial Outcome Index: Cycle 3 (n=145,173) | 58.04 ± 12.80 | 59.33 ± 12.49 |
| Physical Well-Being: Cycle 5 (n=139, 166) | 19.51 ± 4.83 | 19.67 ± 4.56 |
| Social Well-Being: Cycle 5 (n=139, 166) | 19.36 ± 5.26 | 20.68 ± 4.92 |
| Emotional Well-Being: Cycle 5 (n=139, 166) | 16.05 ± 4.44 | 17.07 ± 4.30 |
| Functional Well-Being: Cycle 5 (n=139, 166) | 14.81 ± 5.45 | 15.78 ± 4.77 |
| Total FACT-G Score: Cycle 5 (n=139, 166) | 69.78 ± 15.04 | 73.21 ± 12.49 |
| Breast Specific: Cycle 5 (n=139, 166) | 21.65 ± 5.83 | 23.15 ± 4.90 |
| Total FACT-B Score: Cycle 5 (n=139, 166) | 91.43 ± 18.81 | 96.36 ± 15.63 |
| Trial Outcome Index: Cycle 5 (n=139, 166) | 55.99 ± 13.09 | 58.59 ± 11.01 |
| Physical Well-Being: Cycle 11 (n=100, 133) | 21.71 ± 4.54 | 21.56 ± 4.53 |
| Social Well-Being: Cycle 11 (n=100, 133) | 19.71 ± 5.74 | 20.78 ± 4.92 |
| Emotional Well-Being: Cycle 11 (n=100, 133) | 15.96 ± 4.50 | 17.46 ± 3.70 |
| Functional Well-Being: Cycle 11 (n=100, 133) | 16.25 ± 5.16 | 16.98 ± 4.92 |
| Total FACT-G Score: Cycle 11 (n=100, 133) | 73.26 ± 15.24 | 76.55 ± 13.56 |
| Breast Specific: Cycle 11 (n=100, 133) | 21.29 ± 5.55 | 23.80 ± 4.92 |
| Total FACT-B Score: Cycle 11 (n=100, 133) | 94.57 ± 18.58 | 100.43 ± 16.97 |
| Trial Outcome Index: Cycle 11 (n=100, 133) | 59.19 ± 12.00 | 62.34 ± 11.79 |
| Physical Well-Being: Post PD (n=33, 39) | 19.94 ± 4.99 | 20.35 ± 5.37 |
| Social Well-Being: Post PD (n=33, 39) | 19.02 ± 5.61 | 19.68 ± 4.77 |
| Emotional Well-Being: Post PD (n=33, 39) | 14.76 ± 4.83 | 14.77 ± 4.64 |
| Functional Well-Being: Post PD (n=33, 39) | 14.13 ± 5.57 | 15.08 ± 5.16 |
| Total FACT-G Score: Post PD (n=33, 39) | 67.84 ± 14.21 | 70.04 ± 15.08 |
| Breast Specific: Post PD (n=33, 39) | 22.90 ± 4.48 | 22.87 ± 5.14 |
| Total FACT-B Score: Post PD (n=33, 39) | 90.74 ± 16.59 | 92.92 ± 18.47 |
| Trial Outcome Index: Post PD (n=33, 39) | 56.97 ± 11.16 | 58.47 ± 12.43 |
FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.
| units on a scale | Trastuzumab + Docetaxel | Trastuzumab + Bevacizumab + Docetaxel |
|---|---|---|
| Physical Well-Being: Cycle 3 (n=145,173) | -1.01 ± 7.54 | -1.51 ± 7.16 |
| Social Well-Being: Cycle 3 (n=145,173) | 0.05 ± 7.83 | 0.32 ± 7.93 |
| Emotional Well-Being: Cycle 3 (n=145,173) | 1.52 ± 6.49 | 1.16 ± 6.22 |
| Functional Well-Being: Cycle 3 (n=145, 173) | -0.91 ± 7.90 | -0.16 ± 7.63 |
| Total FACT-G Score: Cycle 3 (n=145,173) | -0.36 ± 22.25 | -0.44 ± 20.40 |
| Breast Specific: Cycle 3 (n=145,173) | 0.61 ± 8.65 | 0.34 ± 7.92 |
| Total FACT-B Score: Cycle 3 (n=145,173) | 0.29 ± 27.63 | -0.24 ± 25.12 |
| Trial Outcome Index: Cycle 3 (n=145,173) | -1.50 ± 18.99 | -1.52 ± 17.75 |
| Physical Well-Being: Cycle 5 (n=139, 166) | -1.69 ± 7.50 | -1.80 ± 6.82 |
| Social Well-Being: Cycle 5 (n=139, 166) | -1.23 ± 7.79 | -0.20 ± 7.58 |
| Emotional Well-Being: Cycle 5 (n=139, 166) | 1.09 ± 6.65 | 1.53 ± 6.18 |
| Functional Well-Being: Cycle 5 (n=139, 166) | -1.53 ± 7.98 | -0.58 ± 7.33 |
| Total FACT-G Score: Cycle 5 (n=139, 166) | -3.53 ± 22.40 | -1.28 ± 19.14 |
| Breast Specific: Cycle 5 (n=139, 166) | -0.03 ± 8.68 | 0.31 ± 7.63 |
| Total FACT-B Score: Cycle 5 (n=139, 166) | -3.55 ± 27.82 | -1.10 ± 23.62 |
| Trial Outcome Index: Cycle 5 (n=139, 166) | -3.55 ± 19.19 | -2.26 ± 16.74 |
| Physical Well-Being: Cycle 11 (n=100, 133) | 0.51 ± 7.32 | 0.09 ± 6.80 |
| Social Well-Being: Cycle 11 (n=100, 133) | -0.89 ± 8.13 | -0.10 ± 7.58 |
| Emotional Well-Being: Cycle 11 (n=100, 133) | 1.00 ± 6.69 | 1.92 ± 5.78 |
| Functional Well-Being: Cycle 11 (n=100, 133) | -0.09 ± 7.79 | 0.62 ± 7.43 |
| Total FACT-G Score: Cycle 11 (n=100, 133) | -0.05 ± 22.54 | 2.06 ± 19.85 |
| Breast Specific: Cycle 11 (n=100, 133) | -0.38 ± 8.49 | 0.96 ± 7.64 |
| Total FACT-B Score: Cycle 11 (n=100, 133) | -0.41 ± 27.67 | 2.97 ± 24.53 |
| Trial Outcome Index: Cycle 11 (n=100, 133) | -0.35 ± 18.46 | 1.49 ± 17.26 |
| Physical Well-Being: Post PD (n=33, 39) | -1.25 ± 7.61 | -1.12 ± 7.39 |
| Social Well-Being: Post PD (n=33, 39) | -1.58 ± 8.03 | -1.19 ± 7.48 |
| Emotional Well-Being: Post PD (n=33, 39) | -0.20 ± 6.92 | -0.78 ± 6.42 |
| Functional Well-Being: Post PD (n=33, 39) | -2.22 ± 8.06 | -1.28 ± 7.59 |
| Total FACT-G Score: Post PD (n=33, 39) | -5.46 ± 21.85 | -4.44 ± 20.92 |
| Breast Specific: Post PD (n=33, 39) | 1.22 ± 7.84 | 0.03 ± 7.79 |
| Total FACT-B Score: Post PD (n=33, 39) | -4.23 ± 26.37 | -4.55 ± 25.59 |
| Trial Outcome Index: Post PD (n=33, 39) | -2.57 ± 17.92 | -2.38 ± 17.70 |
Collected over From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Trastuzumab + Docetaxel | — | 63/206 (30.6%) | 198/206 (96.1%) |
| Trastuzumab + Bevacizumab + Docetaxel | — | 72/215 (33.5%) | 202/215 (94%) |
| Event | Trastuzumab + Docetaxel | Trastuzumab + Bevacizumab + Docetaxel |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 14/206 | 18/215 |
| NeutropeniaBlood and lymphatic system disorders | 9/206 | 6/215 |
| Neutropenic sepsisInfections and infestations | 3/206 | 6/215 |
| DiarrhoeaGastrointestinal disorders | 4/206 | 6/215 |
| Neutropenic infectionInfections and infestations | 2/206 | 4/215 |
| Anal abscessInfections and infestations | 0/206 | 4/215 |
| ErysipelasInfections and infestations | 3/206 | 0/215 |
| VomitingGastrointestinal disorders | 0/206 | 3/215 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/206 | 3/215 |
| PneumoniaInfections and infestations | 2/206 | 1/215 |
| Event | Trastuzumab + Docetaxel | Trastuzumab + Bevacizumab + Docetaxel |
|---|---|---|
| AlopeciaSkin and subcutaneous tissue disorders | 141/206 | 135/215 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 35/206 | 109/215 |
| DiarrhoeaGastrointestinal disorders | 85/206 | 107/215 |
| StomatitisGastrointestinal disorders | 61/206 | 95/215 |
| NauseaGastrointestinal disorders | 76/206 | 82/215 |
| AstheniaGeneral disorders | 76/206 | 75/215 |
| HypertensionVascular disorders | 27/206 | 79/215 |
| Oedema peripheralGeneral disorders | 72/206 | 37/215 |
| Lacrimation increasedEye disorders | 59/206 | 75/215 |
| FatigueGeneral disorders | 48/206 | 69/215 |
Intent-to-treat (ITT) population: All randomized participants, regardless of whether they actually received study treatment or not.
| Age, Continuous(years) | Trastuzumab + Docetaxel | Trastuzumab + Bevacizumab + Docetaxel | Total |
|---|---|---|---|
| Mean | 54.0 ± 11.71 | 53.5 ± 10.90 | 53.7 ± 11.29 |
| Sex: Female, Male(Participants) | Trastuzumab + Docetaxel | Trastuzumab + Bevacizumab + Docetaxel | Total |
|---|---|---|---|
| Female | 208 | 216 | 424 |
| Male | 0 | 0 | 0 |
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hoffmann-La Roche