Trial Outcomes & Findings for Paclitaxel, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer (NCT NCT01276041)
NCT ID: NCT01276041
Last Updated: 2020-08-03
Results Overview
Patients who are considered progression-free at 6 months are deemed successes. Failures are those patients who progressed before the 6 month mark. 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 non-target lesion, or the appearance of new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
6 months
Results posted on
2020-08-03
Participant Flow
Participant milestones
| Measure |
Pertuzumab in Combination With Trastuzumab and Paclitaxel
This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
67
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Pertuzumab in Combination With Trastuzumab and Paclitaxel
This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Paclitaxel, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Pertuzumab in Combination With Trastuzumab and Paclitaxel
n=70 Participants
This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
|
|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPatients who are considered progression-free at 6 months are deemed successes. Failures are those patients who progressed before the 6 month mark. 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 non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Pertuzumab in Combination With Trastuzumab and Paclitaxel
n=70 Participants
This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
|
|---|---|
|
Percentage of Patients Who Are Progression Free at 6 Months or Later.
|
86 percentage of partcipants
Interval 75.0 to 93.0
|
SECONDARY outcome
Timeframe: every 4th cycle CT of chest and abdomen +/- pelvis up to 24 monthsExtent of disease evaluation will consist of a CT of chest and abdomen +/- pelvis. Bone scan and PET are optional. Every 4th cycle, this can be done within +/- 2 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",
Outcome measures
| Measure |
Pertuzumab in Combination With Trastuzumab and Paclitaxel
n=70 Participants
This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
|
|---|---|
|
Number of Participants by Response Rate Using the RECIST Criteria (Version 1.1)
Progression of Disease
|
1 Participants
|
|
Number of Participants by Response Rate Using the RECIST Criteria (Version 1.1)
Not Evaulable
|
10 Participants
|
|
Number of Participants by Response Rate Using the RECIST Criteria (Version 1.1)
Complete Response
|
15 Participants
|
|
Number of Participants by Response Rate Using the RECIST Criteria (Version 1.1)
Partial Response
|
27 Participants
|
|
Number of Participants by Response Rate Using the RECIST Criteria (Version 1.1)
Stable Disease
|
17 Participants
|
SECONDARY outcome
Timeframe: baseline and every 4th cycle of treatment up to 24 monthsWe will also assess the LVEF at baseline and after every 4th cycle of treatment with an ECHO with a strain imaging analysis. When an ECHO cannot be done, a MUGA scan may be done.Patients who have surpassed the 6 month period may complete ECHO with strain imaging analysis or MUGA every 6 months +/- 1 month starting from the most recent ECHO scan date. This study will use the NCI Common Toxicity Criteria (CTC) AE version 4.0 for toxicity.
Outcome measures
| Measure |
Pertuzumab in Combination With Trastuzumab and Paclitaxel
n=70 Participants
This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
|
|---|---|
|
Number of Participants Evaluated for Cardiac Safety
|
70 Participants
|
SECONDARY outcome
Timeframe: 2 yearsThis study will use the NCI Common Toxicity Criteria (CTC) AE version 4.0 for toxicity.
Outcome measures
| Measure |
Pertuzumab in Combination With Trastuzumab and Paclitaxel
n=70 Participants
This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
|
|---|---|
|
Number of Participants Evaluated With Toxicity
|
70 Participants
|
Adverse Events
Pertuzumab in Combination With Trastuzumab and Paclitaxel
Serious events: 18 serious events
Other events: 67 other events
Deaths: 36 deaths
Serious adverse events
| Measure |
Pertuzumab in Combination With Trastuzumab and Paclitaxel
n=70 participants at risk
This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
7.1%
5/70 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
1/70 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
1.4%
1/70 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
1.4%
1/70 • 2 years
|
|
Eye disorders
Blurred vision
|
1.4%
1/70 • 2 years
|
|
Infections and infestations
Breast infection
|
1.4%
1/70 • 2 years
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
1/70 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.4%
1/70 • 2 years
|
|
Hepatobiliary disorders
Cholecystitis
|
1.4%
1/70 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
1.4%
1/70 • 2 years
|
|
Psychiatric disorders
Confusion
|
1.4%
1/70 • 2 years
|
|
General disorders
Death NOS
|
1.4%
1/70 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/70 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
2/70 • 2 years
|
|
Nervous system disorders
Dizziness
|
1.4%
1/70 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
2/70 • 2 years
|
|
Ear and labyrinth disorders
Ear pain
|
1.4%
1/70 • 2 years
|
|
Nervous system disorders
Edema cerebral
|
2.9%
2/70 • 2 years
|
|
General disorders
Edema limbs
|
1.4%
1/70 • 2 years
|
|
Eye disorders
Eye disorders - Other, specify
|
2.9%
2/70 • 2 years
|
|
General disorders
Fatigue
|
4.3%
3/70 • 2 years
|
|
General disorders
Fever
|
4.3%
3/70 • 2 years
|
|
General disorders
Gait disturbance
|
1.4%
1/70 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.4%
1/70 • 2 years
|
|
Nervous system disorders
Headache
|
4.3%
3/70 • 2 years
|
|
Vascular disorders
Hematoma
|
1.4%
1/70 • 2 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.4%
1/70 • 2 years
|
|
Nervous system disorders
Hydrocephalus
|
1.4%
1/70 • 2 years
|
|
Vascular disorders
Hypertension
|
2.9%
2/70 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.4%
1/70 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.4%
1/70 • 2 years
|
|
Vascular disorders
Hypotension
|
1.4%
1/70 • 2 years
|
|
Infections and infestations
Infections and infestations - other, specify
|
2.9%
2/70 • 2 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.4%
1/70 • 2 years
|
|
Investigations
Lipase increased
|
1.4%
1/70 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.4%
1/70 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal & conn tissue disorder Other, spec
|
1.4%
1/70 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
2.9%
2/70 • 2 years
|
|
Nervous system disorders
Nervous system disorders - other, specify
|
1.4%
1/70 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
1.4%
1/70 • 2 years
|
|
Cardiac disorders
Pericardial effusion
|
1.4%
1/70 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/70 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/70 • 2 years
|
|
Nervous system disorders
Seizure
|
2.9%
2/70 • 2 years
|
|
Infections and infestations
Sepsis
|
1.4%
1/70 • 2 years
|
|
Investigations
Serum amylase increased
|
1.4%
1/70 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders Other, spec
|
1.4%
1/70 • 2 years
|
|
Infections and infestations
Skin infection
|
4.3%
3/70 • 2 years
|
|
Nervous system disorders
Syncope
|
1.4%
1/70 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
2.9%
2/70 • 2 years
|
Other adverse events
| Measure |
Pertuzumab in Combination With Trastuzumab and Paclitaxel
n=70 participants at risk
This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
85.7%
60/70 • 2 years
|
|
General disorders
Fatigue
|
88.6%
62/70 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
81.4%
57/70 • 2 years
|
|
Nervous system disorders
Peripheral neuropathy
|
84.3%
59/70 • 2 years
|
|
Investigations
AST/ALT elevation
|
72.9%
51/70 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
61.4%
43/70 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
62.9%
44/70 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
60.0%
42/70 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
60.0%
42/70 • 2 years
|
|
Skin and subcutaneous tissue disorders
Acneiform rash
|
54.3%
38/70 • 2 years
|
|
Gastrointestinal disorders
Mucositis
|
52.9%
37/70 • 2 years
|
|
General disorders
Peripheral edema
|
51.4%
36/70 • 2 years
|
|
Vascular disorders
Hot flashes
|
51.4%
36/70 • 2 years
|
|
Eye disorders
Xerophthalmia
|
47.1%
33/70 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
42.9%
30/70 • 2 years
|
|
Eye disorders
Epiphora
|
42.9%
30/70 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
41.4%
29/70 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
28/70 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
28/70 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hand-foot syndrome
|
38.6%
27/70 • 2 years
|
Additional Information
Dr. Chau Dang, MD
Memorial Sloan Kettering Cancer Center
Phone: 914-367-7181
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place