A Phase 2 interventional study of Liposomal Doxorubicin and Cyclophosphamide in Breast Cancer, sponsored by Spanish Breast Cancer Research Group. Completed at 12 sites in Spain. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-04.
Sponsored by Spanish Breast Cancer Research Group · Phase 2, Interventional, and Treatment
Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks.
Sample size calculation will be done by means of Simon's method in 2 stages for phase II studies and will be based on the principal aim of the study (evaluation of the rate of objective response).
The hypothesis brings over of the efficiency of the treatment it will be accepted if a rate of objective response of at least 55 % is obtained, rejecting the efficiency of the treatment when the rate of response targets be lower than 35 %. In this case, considering an alpha error of 0.05 and 80 % power, 14 patients will be included in the first stage; the study would continue if more than 5 objective responses were found. The total number of patients to including in the study would be 44. The results will be significant if they find at least 20 objective responses.
Assuming a drop-out rate of 10 %, the total number of patients needed is 49 patients.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 49 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Spanish Breast Cancer Research Group is the lead sponsor of 48 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Drug: Liposomal Doxorubicin · Drug: Cyclophosphamide · Drug: Trastuzumab
Also known as: Caelyx
Also known as: Cytoxan
Also known as: Herceptin
Objective Response Rate (ORR)
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.
Time frame: Up to cycle 6 (24 weeks)
Time to Progression (TTP)
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
Time frame: Through study treatment, and follow up period, assessed up to 88 weeks
Time to Treatment Failure (TTF)
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.
Time frame: Through study treatment, and follow up period, assessed up to 88 weeks
Response Duration
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.
Time frame: Through study treatment, and follow up period, assessed up to 88 weeks
Overall Survival (OS)
OS was defined as the time elapsed from first treatment until death from any cause.
Time frame: Through study treatment, and follow up period, assessed up to 88 weeks
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.
| Milestone | Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab |
|---|---|
| Started | 49 |
| Completed | 32 |
| Not completed | 17 |
| Withdrew: Death | 2 |
| Withdrew: Disease progression | 7 |
| Withdrew: Adverse event | 4 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Mistake | 2 |
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.
| Participants | Caelyx,Cyclophosphamide,Trastuzumab |
|---|---|
| Objective Response Rate (ORR) | 33 |
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
| Months | Caelyx,Cyclophosphamide,Trastuzumab |
|---|---|
| Time to Progression (TTP) | 12 (9 to 15.1) |
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.
| Months | Caelyx,Cyclophosphamide,Trastuzumab |
|---|---|
| Time to Treatment Failure (TTF) | 9.7 (7.9 to 11.4) |
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.
| Months | Caelyx,Cyclophosphamide,Trastuzumab |
|---|---|
| Response Duration | 9.51 (7.28 to 11.73) |
OS was defined as the time elapsed from first treatment until death from any cause.
| Months | Caelyx,Cyclophosphamide,Trastuzumab |
|---|---|
| Overall Survival (OS) | 34.2 (27.2 to 41.2) |
Collected over Deaths were assessed for up to 88 weeks. Adverse Events were assessed up to 84 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab | 2/48 (4.2%) | 16/48 (33.3%) | 48/48 (100%) |
| Event | Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab |
|---|---|
| Febrile neutropenia grade 3Blood and lymphatic system disorders | 3/48 |
| Hypersensibility reaction grade 3General disorders | 2/48 |
| Cerebrovascular ischemiaNervous system disorders | 1/48 |
| Hemorrhage CNS grade 5Nervous system disorders | 1/48 |
| Infection with normal ANC (skin celluties grade 3)Skin and subcutaneous tissue disorders | 1/48 |
| Acute respiratory insufficiencyRespiratory, thoracic and mediastinal disorders | 1/48 |
| Catheter - related infection grade 3Infections and infestations | 1/48 |
| Holocraneal cephaleaGeneral disorders | 1/48 |
| Neutropenia grade 3Blood and lymphatic system disorders | 1/48 |
| Hemorrhage subarachnoidVascular disorders | 1/48 |
| Event | Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab |
|---|---|
| HemoglobinBlood and lymphatic system disorders | 27/48 |
| Heartburn/dyspepsiaGastrointestinal disorders | 20/48 |
| ALT, SGPTMetabolism and nutrition disorders | 20/48 |
| Left Ventricular diastolic dysfunctionCardiac disorders | 19/48 |
| AST, SGOTMetabolism and nutrition disorders | 18/48 |
| FatigueGeneral disorders | 16/48 |
| NauseaGastrointestinal disorders | 16/48 |
| Rash: Hand-foot skin reactionSkin and subcutaneous tissue disorders | 14/48 |
| LeukocytesBlood and lymphatic system disorders | 14/48 |
| Rash: Hand-foot skin reactionSkin and subcutaneous tissue disorders | 13/48 |
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.
| Age, Continuous(years) | Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab |
|---|---|
| Median | 57 (37 to 78) |
| Sex: Female, Male(Participants) | Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab |
|---|---|
| Female | 48 |
| Male | 0 |
| Eastern Cooperative Oncology Group (ECOG)(Participants) | Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab |
|---|---|
| ECOG 0 | 26 |
| ECOG 1 | 20 |
| ECOG 2 | 2 |
| Menopausal Status(Participants) | Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab |
|---|---|
| Premenopausal | 9 |
| Postmenopausal | 39 |
| Hormonal receptor status(Participants) | Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab |
|---|---|
| Positive | 24 |
| Negative | 24 |
| Disease stage at diagnosis(Participants) | Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab |
|---|---|
| Stage I to III | 26 |
| Stage IV | 22 |
| Prior neo(adjuvant) chemotherapy(Participants) | Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab |
|---|---|
| Prior neo(adjuvant) chemotherapy | 23 |
| Non Prior neo(adjuvant) chemotherapy | 25 |
| Number of disease sites(Participants) | Liposomal Doxorubicin,Cyclophosphamide,Trastuzumab |
|---|---|
| 1 disease site | 10 |
| 2 disease sites | 18 |
| 3 disease sites or more | 20 |
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Spanish Breast Cancer Research Group