An observational study in Breast Neoplasm, sponsored by Merck Sharp & Dohme LLC. Completed. Per ClinicalTrials.gov, last updated 2014-11-05.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Observational
This is a study to evaluate the safety and tolerability of Caelyx used for the treatment of metastatic breast cancer (MBC), focusing on infusion reaction and palmar-plantar erythrodysesthesia (PPE).
Patients selected by investigator according to clinical routine
12,820 studies on the registry are indexed under Breast Neoplasms; 2,923 are open to participants now.
This study's enrollment of 167 is close to the median of 185 across 2,712 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,160 studies on the registry; 134 are open to participants now.
Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.
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Patients with metastatic breast cancer
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Exclusion Criteria:
Subjects with metastatic breast cancer
Drug: Pegylated Liposomal Doxorubicin
Pegylated Liposomal Doxorubicin (Caelyx) 50 mg/m\^2, given for up to 6 cycles
Also known as: SCH 200746
Number of Participants With Infusion Reactions (IR)
Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia.
Time frame: Day 1 up to Week 24
Percent of Participants Taking Premedication for Prevention of IR
Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers.
Time frame: Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin
Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR
Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria.
Time frame: Cycles 1 & 3 (Week 4 & Week 12)
Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE)
PPE was defined as a dermatological adverse event characterized by swelling, pain, edema, erythema, desquamation, that may have ultimately resulted in fissuring and ulceration, involving fingers, toes, palms, plantar aspects of the feet, and other pressure-sensitive areas of the skin.
Time frame: Up to 24 weeks
Number of Times Premedications Were Given for Prevention of PPE
Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.
Time frame: Day 1 up to 24 weeks
Number of Participants With Complete Response (CR) or Partial Response (PR)
CR and PR were documented according to the clinical standards of each site.
Time frame: Day 1 up to 24 weeks
| Milestone | Pegylated Liposomal Doxorubicin |
|---|---|
| Started | 167 |
| Completed | 56 |
| Not completed | 111 |
| Withdrew: Did not receive drug or not documented | 7 |
| Withdrew: Data missing | 2 |
| Withdrew: Tumor progression | 75 |
| Withdrew: Toxicity | 6 |
| Withdrew: Withdrawal by subject | 10 |
| Withdrew: Death | 7 |
| Withdrew: Other | 4 |
Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia.
| Participants | Pegylated Liposomal Doxorubicin |
|---|---|
| Number of Participants With Infusion Reactions (IR) | 7 |
CR and PR were documented according to the clinical standards of each site.
| Participants | Pegylated Liposomal Doxorubicin |
|---|---|
| CR | 2 |
| PR | 29 |
Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers.
| Percent of participants | Pegylated Liposomal Doxorubicin |
|---|---|
| Corticosteroids | 96.3 |
| Serotonin-3 receptor antagonists (anti-emetics) | 97.5 |
| Histamine-1 receptor blockers | 15.6 |
| Histamine-2 receptor blockers | 36.3 |
Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria.
| Participants | Pegylated Liposomal Doxorubicin |
|---|---|
| Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR | 0 |
PPE was defined as a dermatological adverse event characterized by swelling, pain, edema, erythema, desquamation, that may have ultimately resulted in fissuring and ulceration, involving fingers, toes, palms, plantar aspects of the feet, and other pressure-sensitive areas of the skin.
| Occurrences | Pegylated Liposomal Doxorubicin |
|---|---|
| Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE) | 91 |
Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.
| Number of times premedication was given | Pegylated Liposomal Doxorubicin |
|---|---|
| Oral dexamethasone | 66 |
| Vitamin B6 | 70 |
| Other | 49 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pegylated Liposomal Doxorubicin | — | 5/160 (3.1%) | 9/160 (5.6%) |
| Event | Pegylated Liposomal Doxorubicin |
|---|---|
| General physical health deteriorationGeneral disorders | 2/160 |
| LeukopeniaBlood and lymphatic system disorders | 1/160 |
| Bone painMusculoskeletal and connective tissue disorders | 1/160 |
| UrticariaSkin and subcutaneous tissue disorders | 1/160 |
| Event | Pegylated Liposomal Doxorubicin |
|---|---|
| StomatitisGastrointestinal disorders | 9/160 |
| Age, Continuous(years) | Pegylated Liposomal Doxorubicin |
|---|---|
| Mean | 62 ± 12 |
| Sex: Female, Male(Participants) | Pegylated Liposomal Doxorubicin |
|---|---|
| Female | 159 |
| Male | 1 |
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