A Double-blind Randomised, Parallel Phase I/IIb Study to Evaluate Initial Safetyand Efficacy, Comparative Pharmacokinetics and Immunogenicity for CT-P6 andHerceptin in Metastatic Breast Cancer

Phase 1

Active, not recruiting

• Conditions: Metastatic breast cancer; MedDRA version: 12.0Level: LLTClassification code 10027475Term: Metastatic breast cancer

• Registration Number: EUCTR2009-014463-39-LV
• Lead Sponsor: Celltrion, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-08
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Female
• Target Recruitment: 170

Inclusion Criteria

1. Written and signed informed consent, obtained prior to starting any protocol-specific procedures.
2. Are females over 18 years of age.
3. Have pathologically confirmed, uni-dimensionally measurable metastatic breast
cancer.
4. Have a strong Her-2 over-expression as described by a 3+ score by immunohistochemistry (IHC) or a positive fluorescence in-situ hybridisation (FISH) or chromogenic in-situ hybridisation (CISH) result.
5. Have target lesions outside prior radiation fields.
6. Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
7. Have at least 4 weeks since last surgery or radiation therapy, with full recovery.
Patients must have received no radiotherapy for the treatment of metastatic disease.
However, patients who have received adjuvant radiotherapy as part of the treatment of early breast cancer are eligible if the last fraction of radiotherapy was administered at least 6 months prior to randomisation.
Radiotherapy administered for the relief of metastatic bone pain other than the sole site of measurable diseases is allowed, but:
o no more than 25% of marrow-bearing bone should have been irradiated,
o the last fraction of radiotherapy should not have been administered within 4 weeks prior to randomisation,
o patients must have recovered from all treatment-related toxicities prior to randomisation.
8. Regarding trastuzumab treatment;
o Have never been treated with trastuzumab, or
o Prior trastuzumab and chemotherapy (taxane included) or trastuzumab alone as neoadjuvant/adjuvant treatment is discontinued > 12 months prior to randomisation.
9. Bisphosphonate therapy for bone metastases is allowed; however, treatment must be initiated prior to the first dose of randomised therapy. Prophylactic use of bisphosphonates in patients without bone diseases is not permited, except for the treatment of osteoporosis.
10. Laboratory requirements as defined below:
Haematology: Absolute neutrophil count (ANC): =1,500/mm EXP 3 (1.5 x 10 EXP 9 cells/L); Platelets: = 100,000/mm EXP 3 (100 x 10 EXP 9 cells/L); Haemoglobin: = 9.0 g/dL;
Liver function: Total bilirubin: = 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): = 2.5 x ULN, or = 5.0 x ULN in the case of liver metastasis;
Renal function: Serum creatinine: = 2 mg/dL
11. Are expected to survive for at least 6 months.
12. Are not pregnant and do not plan to become pregnant during the study.
For females of childbearing potential, pregnancy tests must be performed via serum
pregnancy test at baseline (within 7 days prior to starting study drug) and at the end
of treatment. Further tests are only required if there is a suspicion of pregnancy. If
sexually active, must be using at least one reliable method of contraception (e.g., a
barrier method [condom or occlusive cap] with spermicidal
foam/gel/film/cream/suppository, an intrauterine device [IUD] or intrauterine
system [IUS], oral or injectable contraception, sterilisation of sole male partner,
abstinence) throughout the study period and for 6 months after the last study drug
treatment.
Non-childbearing potential is defined as:
- aged =50 years and naturally amenorrhoeic for at least 1 year*, or
- premature ovarian failure confirmed by a specialist gynaecologist, or
- previous bilateral salpingo-oophorectomy or hysterectomy, or
- XY genotype, Turner’s syndrome, uterine agenesis.
* Amenorrhoea following cancer therapy does not rule out childbearing potential.
Are the tr

Exclusion Criteria

1. Have received prior chemotherapy for metastatic breast cancer.
2. Current clinical or radiographic evidence of central nervous system (CNS)
metastases. A computerised tomography (CT) or magnetic resonance imaging
(MRI) scan of the brain is mandatory in cases of clinical suspicion of brain
metastases within 21 days of randomisation. Eligible patients must be
asymptomatic and cannot be receiving steroids.
3. Are receiving concurrent immunotherapy or hormonal therapy.
4. Have a history of congestive heart failure (CHF) of any New York Heart
Association (NYHA) criterion, or serious cardiac arrhythmia requiring treatment
(except for atrial fibrillation and/or paroxysmal supraventricular tachycardia).
5. Have an abnormal LVEF (=50%) at baseline, as determined by either
two-dimensional echocardiogram (ECHO) or multiple-gated acquisition (MUGA)
scan. If the patient is randomised, the same method of LVEF assessment, ECHO
or MUGA, must be used throughout the study.
6. History of myocardial infarction within 6 months before randomisation.
7. Current uncontrolled hypertension (systolic blood pressure >150 mmHg and/or
diastolic blood pressure >100 mmHg), or unstable angina.
8. Have severe dyspnoea at rest due to complications of advanced malignancy or
requiring supplementary oxygen therapy.
9. Have had a prior malignancy within the last 5 years that might affect breast
cancer diagnosis or assessment.
10. Have had prior mediastinal irradiation (except internal mammary-node irradiation
for the present breast cancer).
11. Have received cumulative doses of anthracycline exceeding 360 mg/m2 of body
surface area for doxorubicin, 720 mg/m2 for epirubicin, 120 mg/m2 for
mitoxantrone, 90 mg/m2 for idarubicin, or the equivalent of 360 mg/m2 of
doxorubicin for other anthracyclines such as liposomal doxorubicin. If more than
one anthracycline has been used, then the cumulative dose must not exceed the
equivalent of 360 mg/m2 of doxorubicin.
12. Have a history of hypersensitivity to the trastuzumab or to drugs with similar
chemical structures, or to any of the excipients, or to murine proteins.
13. Have a history of severe hypersensitivity reaction to paclitaxel, or to any of the
excipients.
14. Have peripheral neuropathy of grade 2 or greater
15. Have active or uncontrolled infection
16. Have any other medical or psychiatric condition that could compromise study participation.
17. Have received treatment with any other investigational drug in the last 30 days before study entry, or within less than five half-lives after receiving the previous investigational drug
18. Current known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
19. Are pregnant or a nursing mother.
20. Have a history or suspicion of unreliability, poor cooperation or non-compliance
with medical treatment.
21. Have any concurrent disease or condition that, in the opinion of the investigator,
would make the patient unsuitable for participation in the study.
22. Have previously been randomised in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified