Trial Outcomes & Findings for A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer (NCT NCT02005549)
NCT ID: NCT02005549
Last Updated: 2014-07-14
Results Overview
pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])
Results posted on
2014-07-14
Participant Flow
Participant milestones
| Measure |
Bevacizumab+Docetaxel+Capecitabine
Participants received bevacizumab, 15 milligrams/kilogram (mg/kg) intravenously (IV), followed by docetaxel 75 mg per square meter (mg/m\^2) IV on Day 1 and capecitabine 950 mg/m\^2 orally (PO) twice daily (BID) within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
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|---|---|
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Overall Study
STARTED
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18
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Overall Study
COMPLETED
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18
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab+Docetaxel+Capecitabine
n=18 Participants
Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m\^2 IV on Day 1 and capecitabine 950 mg/m\^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
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|---|---|
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Age, Continuous
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48 years
n=5 Participants
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Sex: Female, Male
Female
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18 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])Population: ITT population; participants evaluable for response included those participants who received a minimum of 3 cycles of treatment (9 weeks on study) with final surgery performed and the samples and reports available.
pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle.
Outcome measures
| Measure |
Bevacizumab+Docetaxel+Capecitabine
n=18 Participants
Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m\^2 IV on Day 1 and capecitabine 950 mg/m\^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
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|---|---|
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Percentage of Participants With Pathological Complete Response (pCR)
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22.22 percentage of participants
Interval 6.41 to 47.64
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SECONDARY outcome
Timeframe: Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])Population: ITT population; participants evaluable for response included those participants who received a minimum of 3 cycles of treatment (9 weeks on study) with final surgery performed and the samples and reports available.
Percentage of participants with pCR plus the percentage of participants without pCR who achieved CR or PR as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. 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 axis 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.
Outcome measures
| Measure |
Bevacizumab+Docetaxel+Capecitabine
n=18 Participants
Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m\^2 IV on Day 1 and capecitabine 950 mg/m\^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
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|---|---|
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Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR)
|
72.22 percentage of participants
Interval 46.52 to 90.31
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SECONDARY outcome
Timeframe: 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])Population: ITT population.
Percentage of participants undergoing a breast-conserving procedure versus a modified radical mastectomy at final surgery, performed 2 to 4 weeks after the last chemotherapy cycle (Week 18)
Outcome measures
| Measure |
Bevacizumab+Docetaxel+Capecitabine
n=18 Participants
Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m\^2 IV on Day 1 and capecitabine 950 mg/m\^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
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|---|---|
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Percentage of Participants Undergoing Breast-Conserving Surgery
|
83 percentage of participants
Interval 59.0 to 96.0
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Adverse Events
Bevacizumab+Docetaxel+Capecitabine
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab+Docetaxel+Capecitabine
n=18 participants at risk
Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m\^2 IV on Day 1 and capecitabine 950 mg/m\^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
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|---|---|
|
Vascular disorders
Deep vein thrombosis
|
11.1%
2/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Gastrointestinal disorders
Intestinal perforation
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
General disorders
General physical health deterioration
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
General disorders
Impaired healing
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Infections and infestations
Neutropenic infection
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Contralateral breast cancer
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Reproductive system and breast disorders
Menorrhagia
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
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Other adverse events
| Measure |
Bevacizumab+Docetaxel+Capecitabine
n=18 participants at risk
Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m\^2 IV on Day 1 and capecitabine 950 mg/m\^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
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|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
94.4%
17/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
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|
Skin and subcutaneous tissue disorders
Nail disorder
|
66.7%
12/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
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|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
16.7%
3/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
3/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
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|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
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|
Gastrointestinal disorders
Constipation
|
44.4%
8/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Gastrointestinal disorders
Stomatitis
|
27.8%
5/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
4/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Gastrointestinal disorders
Diarrhoea
|
22.2%
4/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
3/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Gastrointestinal disorders
Duodenitis
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Gastrointestinal disorders
Eructation
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Gastrointestinal disorders
Gastritis
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Gastrointestinal disorders
Intestinal perforation
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Gastrointestinal disorders
Melaena
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
44.4%
8/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Blood and lymphatic system disorders
Anaemia
|
27.8%
5/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.7%
3/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
3/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Investigations
Blood lactate dehydrogenase increased
|
44.4%
8/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Investigations
Weight decreased
|
27.8%
5/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Investigations
Alanine aminotransferased increased
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Investigations
C-reactive protein increased
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Investigations
Pulse abnormal
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
44.4%
8/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
3/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
2/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
General disorders
Fatigue
|
33.3%
6/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
General disorders
Asthenia
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
General disorders
General physical health deterioration
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
General disorders
Impaired healing
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
General disorders
Mucosal inflammation
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
General disorders
Oedema peripheral
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
General disorders
Pyrexia
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Nervous system disorders
Dysgeusia
|
22.2%
4/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Nervous system disorders
Polyneuropathy
|
22.2%
4/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Infections and infestations
Rhinitis
|
16.7%
3/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Infections and infestations
Laryngitis
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Infections and infestations
Neutropenic infection
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Infections and infestations
Oral herpes
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
6/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Psychiatric disorders
Depression
|
11.1%
2/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Psychiatric disorders
Insomnia
|
11.1%
2/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Psychiatric disorders
Sleep disorder
|
11.1%
2/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Psychiatric disorders
Panic attack
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
3/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
11.1%
2/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Vascular disorders
Hot flush
|
16.7%
3/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Vascular disorders
Deep vein thrombosis
|
11.1%
2/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Vascular disorders
Thrombophlebitis
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Reproductive system and breast disorders
Menorrhagia
|
11.1%
2/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Eye disorders
Conjunctivitis
|
11.1%
2/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Eye disorders
Visual acuity reduced
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Cardiac disorders
Cardiovascular disorder
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Cardiac disorders
Pericardial effusion
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Ear and labyrinth disorders
Vertigo
|
11.1%
2/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Injury, poisoning and procedural complications
Wound complications
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Contralateral breast cancer
|
5.6%
1/18 • Baseline, every three weeks (Cycles 1 through 6), end-of-treatment, to 28 days after last dosage of study drug.
An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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 the Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER