A Phase 2 interventional study of bevacizumab [Avastin] and Docetaxel in Breast Cancer, sponsored by Hoffmann-La Roche. Terminated at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-11.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This single arm study will assess the efficacy and safety of combination first-line treatment with docetaxel + Xeloda + Avastin in patients with inflammatory or locally advanced breast cancer. Patients will receive 3-weekly cycles of Avastin (15mg/kg i.v. on day 1 of each cycle), docetaxel (75mg/m2 i.v. on day 1 of each cycle, after Avastin) and Xeloda (2000mg/m2 p.o. on days 1-15 of each cycle). Four cycles of chemotherapy are planned, plus an optional additional two cycles; after chemotherapy patients will be assessed for surgery. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 23 is below 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: Xeloda
15mg/kg iv on day 1 of each 3 week cycle
75mg/m2 iv on day 1 of each 3 week cycle
2000mg/m2 po on days 1-15 of each 3 week cycle
Percentage of Participants Achieving Pathological Complete Response (pCR)
pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.
Time frame: At time of surgery, after receiving up to 6 cycles of treatment (average of 12 to 18 weeks)
Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)
The percentage of participants with a best overall response of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than \[\<\]10 millimeters \[mm\]). No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Time frame: Day 1 of Cycles 1-6
Progression-Free Survival
Progression-free survival was defined as the time from the date of informed consent until the date disease progression was identified, or the date of death from disease progression, whichever occurred first.
Time frame: Cycles 1-6
Overall Survival
Overall survival was defined as the time from the date of informed consent until the date of death due to any cause.
Time frame: Cycles 1-6
Percentage of Participants Undergoing Breast-Conserving Surgery
The percentage of participants who were able to undergo breast-conserving surgical procedures (segmentectomy plus lymphadenectomy or quadrantectomy plus lymphadenectomy) rather than non-breast conserving procedures (radical mastectomy or modified-radical mastectomy) following 4 or more treatment cycles.
Time frame: Following Cycle 6
| Milestone | Bevacizumab+Docetaxel+Capecitabine |
|---|---|
| Started | 23 |
| Completed | 20 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Disease course | 1 |
| Withdrew: Protocol violation | 1 |
pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.
| percentage of participants | Bevacizumab+Docetaxel+Capecitabine |
|---|---|
| Percentage of Participants Achieving Pathological Complete Response (pCR) | 0 |
The percentage of participants with a best overall response of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than \[\<\]10 millimeters \[mm\]). No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
| percentage of participants | Bevacizumab+Docetaxel+Capecitabine |
|---|---|
| Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR) | 80 |
Progression-free survival was defined as the time from the date of informed consent until the date disease progression was identified, or the date of death from disease progression, whichever occurred first.
No measurements were reported for this outcome.
Overall survival was defined as the time from the date of informed consent until the date of death due to any cause.
No measurements were reported for this outcome.
The percentage of participants who were able to undergo breast-conserving surgical procedures (segmentectomy plus lymphadenectomy or quadrantectomy plus lymphadenectomy) rather than non-breast conserving procedures (radical mastectomy or modified-radical mastectomy) following 4 or more treatment cycles.
| percentage of participants | Bevacizumab+Docetaxel+Capecitabine |
|---|---|
| Percentage of Participants Undergoing Breast-Conserving Surgery | 26.09 |
Collected over Throughout study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bevacizumab+Docetaxel+Capecitabine | — | 2/23 (8.7%) | 23/23 (100%) |
| Event | Bevacizumab+Docetaxel+Capecitabine |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 1/23 |
| Disease progressionGeneral disorders | 1/23 |
| Event | Bevacizumab+Docetaxel+Capecitabine |
|---|---|
| StomatitisGastrointestinal disorders | 14/23 |
| Hand-foot syndromeSkin and subcutaneous tissue disorders | 14/23 |
| NeutropeniaBlood and lymphatic system disorders | 11/23 |
| AlopeciaSkin and subcutaneous tissue disorders | 9/23 |
| DiarrhoeaGastrointestinal disorders | 9/23 |
| NauseaGastrointestinal disorders | 8/23 |
| AstheniaGeneral disorders | 6/23 |
| VomitingGastrointestinal disorders | 5/23 |
| Mucous membrane inflammationGeneral disorders | 5/23 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 4/23 |
Intent-to-treat (ITT) population. The ITT population included all enrolled participants.
| Age, Continuous(years) | Bevacizumab+Docetaxel+Capecitabine |
|---|---|
| Mean | 51.96 ± 11.51 |
| Sex: Female, Male(Participants) | Bevacizumab+Docetaxel+Capecitabine |
|---|---|
| Female | 23 |
| Male | 0 |
This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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