Trial Outcomes & Findings for Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer (NCT NCT00258960)
NCT ID: NCT00258960
Last Updated: 2023-04-04
Results Overview
ORR is the sum of the Complete Responses (CR) and Partial Responses (PR) according to the RECIST criteria, experienced for each patient during treatment (recorded from the start of the treatment until disease progression). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan (computed tomography) or MRI (magnetic resonance imaging): 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 Rate (ORR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Up to cycle 6 (24 weeks)
Results posted on
2023-04-04
Participant Flow
Between February 2006 and June 2008, 49 patients were enrolled at 12 Spanish sites. One patient never received treatment due to early death from progressive disease and was not included in this analysis.
Participant milestones
| Measure |
Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab
Liposomal Doxorubicin 50 mg/m2 every 4 weeks for six cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for six cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)
Liposomal Doxorubicin
Cyclophosphamide
Trastuzumab
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab
Liposomal Doxorubicin 50 mg/m2 every 4 weeks for six cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for six cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)
Liposomal Doxorubicin
Cyclophosphamide
Trastuzumab
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Disease Progression
|
7
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Mistake
|
2
|
Baseline Characteristics
Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab
n=48 Participants
Liposomal Doxorubicin 50 mg/m2 every 4 weeks for six cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for six cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)
Liposomal Doxorubicin
Cyclophosphamide
Trastuzumab
|
|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
ECOG 0
|
26 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
ECOG 1
|
20 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
ECOG 2
|
2 Participants
n=5 Participants
|
|
Menopausal Status
Premenopausal
|
9 Participants
n=5 Participants
|
|
Menopausal Status
Postmenopausal
|
39 Participants
n=5 Participants
|
|
Hormonal receptor status
Positive
|
24 Participants
n=5 Participants
|
|
Hormonal receptor status
Negative
|
24 Participants
n=5 Participants
|
|
Disease stage at diagnosis
Stage I to III
|
26 Participants
n=5 Participants
|
|
Disease stage at diagnosis
Stage IV
|
22 Participants
n=5 Participants
|
|
Prior neo(adjuvant) chemotherapy
Prior neo(adjuvant) chemotherapy
|
23 Participants
n=5 Participants
|
|
Prior neo(adjuvant) chemotherapy
Non Prior neo(adjuvant) chemotherapy
|
25 Participants
n=5 Participants
|
|
Number of disease sites
1 disease site
|
10 Participants
n=5 Participants
|
|
Number of disease sites
2 disease sites
|
18 Participants
n=5 Participants
|
|
Number of disease sites
3 disease sites or more
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to cycle 6 (24 weeks)Population: 49 patients included but 1 is not considered due to not receive any treatment and died before start
ORR is the sum of the Complete Responses (CR) and Partial Responses (PR) according to the RECIST criteria, experienced for each patient during treatment (recorded from the start of the treatment until disease progression). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan (computed tomography) or MRI (magnetic resonance imaging): 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 Rate (ORR) = CR + PR.
Outcome measures
| Measure |
Caelyx,Cyclophosphamide,Trastuzumab
n=48 Participants
Caelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)
Liposomal Doxorubicin
Cyclophosphamide
Trastuzumab
|
|---|---|
|
Objective Response Rate (ORR)
|
33 Participants
|
SECONDARY outcome
Timeframe: Through study treatment, and follow up period, assessed up to 88 weeksPopulation: 49 patients included but 1 is not considered due to not receive any treatment and died before start
TTP was defined as the time elapsed from first treatment until clinical evidence of disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), 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 |
Caelyx,Cyclophosphamide,Trastuzumab
n=48 Participants
Caelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)
Liposomal Doxorubicin
Cyclophosphamide
Trastuzumab
|
|---|---|
|
Time to Progression (TTP)
|
12 Months
Interval 9.0 to 15.1
|
SECONDARY outcome
Timeframe: Through study treatment, and follow up period, assessed up to 88 weeksPopulation: 49 patients included but 1 is not considered due to not receive any treatment and died before start
TTF was defined as the time elapsed from first treatment until patient discontinuation due to toxicity, disease progression, death or withdrawal of consent for any reason, whichever occurred first.
Outcome measures
| Measure |
Caelyx,Cyclophosphamide,Trastuzumab
n=48 Participants
Caelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)
Liposomal Doxorubicin
Cyclophosphamide
Trastuzumab
|
|---|---|
|
Time to Treatment Failure (TTF)
|
9.7 Months
Interval 7.9 to 11.4
|
SECONDARY outcome
Timeframe: Through study treatment, and follow up period, assessed up to 88 weeksPopulation: Patients with Overall Response (see ORR objective)
Response duration was defined as the time elapsed from the first evidence of tumor response (Complete response or Partial Response) until clinical evidence of disease progression or death occurred.
Outcome measures
| Measure |
Caelyx,Cyclophosphamide,Trastuzumab
n=33 Participants
Caelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)
Liposomal Doxorubicin
Cyclophosphamide
Trastuzumab
|
|---|---|
|
Response Duration
|
9.51 Months
Interval 7.28 to 11.73
|
SECONDARY outcome
Timeframe: Through study treatment, and follow up period, assessed up to 88 weeksPopulation: 49 patients included but 1 is not considered due to not receive any treatment and died before start
OS was defined as the time elapsed from first treatment until death from any cause.
Outcome measures
| Measure |
Caelyx,Cyclophosphamide,Trastuzumab
n=48 Participants
Caelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)
Liposomal Doxorubicin
Cyclophosphamide
Trastuzumab
|
|---|---|
|
Overall Survival (OS)
|
34.2 Months
Interval 27.2 to 41.2
|
Adverse Events
Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab
Serious events: 16 serious events
Other events: 48 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab
n=48 participants at risk
Liposomal Doxorubicin 50 mg/m2 every 4 weeks for six cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for six cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)
|
|---|---|
|
Nervous system disorders
Cerebrovascular ischemia
|
2.1%
1/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Blood and lymphatic system disorders
Febrile neutropenia grade 3
|
6.2%
3/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Nervous system disorders
Hemorrhage CNS grade 5
|
2.1%
1/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Skin and subcutaneous tissue disorders
Infection with normal ANC (skin celluties grade 3)
|
2.1%
1/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory insufficiency
|
2.1%
1/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Infections and infestations
Catheter - related infection grade 3
|
2.1%
1/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
General disorders
Holocraneal cephalea
|
2.1%
1/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Blood and lymphatic system disorders
Neutropenia grade 3
|
2.1%
1/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Vascular disorders
Hemorrhage subarachnoid
|
2.1%
1/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
General disorders
Hypersensibility reaction grade 3
|
4.2%
2/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
General disorders
Palmoplantar erythrodysesthesia grade 3, stomatitis grade 3
|
2.1%
1/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progression disease
|
2.1%
1/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
General disorders
Neutropenia grade 4, fever grade 1, oral mucositis grade 3
|
2.1%
1/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
Other adverse events
| Measure |
Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab
n=48 participants at risk
Liposomal Doxorubicin 50 mg/m2 every 4 weeks for six cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for six cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytes
|
29.2%
14/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Blood and lymphatic system disorders
Neutrophils / Granulocytes
|
18.8%
9/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
General disorders
Fatigue
|
25.0%
12/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Gastrointestinal disorders
Mucositis / Stomatitis
|
18.8%
9/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
4.2%
2/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Reproductive system and breast disorders
Pneumonitis/Pulmonary infiltrates
|
2.1%
1/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Blood and lymphatic system disorders
Hemoglobin
|
56.2%
27/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Skin and subcutaneous tissue disorders
Rash: Hand-foot skin reaction
|
27.1%
13/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Blood and lymphatic system disorders
Lymphopenia
|
14.6%
7/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Cardiac disorders
Left Ventricular systolic dysfunction
|
16.7%
8/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
16.7%
8/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
41.7%
20/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Cardiac disorders
Left Ventricular diastolic dysfunction
|
39.6%
19/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
General disorders
Fever
|
18.8%
9/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia
|
25.0%
12/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
16.7%
8/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Gastrointestinal disorders
Anorexia
|
16.7%
8/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Gastrointestinal disorders
Nausea
|
33.3%
16/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Infections and infestations
Infection with normal ANC or G1 or 2 neutrophils
|
20.8%
10/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
20.8%
10/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
41.7%
20/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Metabolism and nutrition disorders
AST, SGOT
|
37.5%
18/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
8/48 • Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.
49 patients included but 1 is not considered due to not receive any treatment and died before start
|
Additional Information
Scientific Director / Medical Lead / Project Manager
Spanish Breast Cancer Research Group
Phone: +34 916 592 870
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60