A Phase II, placebo-controlled study of the efficacy, safety and tolerability of Lymfactin® in combination with a surgical lymph node transfer for the treatment of patients with secondary lymphedema associated with the treatment of breast cancer

Phase 1

Conditions: Secondary lymphedema associated with the treatment of breast cancer
MedDRA version: 20.0Level: LLTClassification code 10036389Term: Postmastectomy lymphedema syndromeSystem Organ Class: 100000004863
MedDRA version: 20.0Level: LLTClassification code 10025233Term: LymphedemaSystem Organ Class: 100000004866
MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2017-004443-20-FI

Lead Sponsor: Herantis Pharma Plc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. Female or male patients with secondary lymphedema
associated with the treatment of breast cancer and
a. Has undergone sentinel lymph node biopsies
and/or lymph node resection in the axilla on the
affected side of their breast cancer with initial
N1-N2a staging and lymph node metastasis in
= 9 axillary lymph nodes.
b. Requires garment use as a compression
treatment for the lymphedema in the affected
arm.
c. Has the volume of the affected arm at least
10% greater than the unaffected arm following
7 days without compression garment.
d. Has the presence of pitting edema in the
affected arm without compression garment.
e. Has had lymphedema for less than 5 years.
2. No evidence of recurrent or active breast cancer for at
least 2 years after the breast cancer surgery and/or the
end of chemotherapy and/or radiotherapy (excluding
endocrine treatment).
3. The patient understands and voluntarily signs the
written informed consent prior to any screening
procedure.
4. 18-70 years of age at time of the informed consent.
5. ECOG Performance Status of 0 or 1.
6. BMI between 18 and 32 inclusive.
7. PET CT scan of the chest and the abdomen within 45
days before the study treatment without signs of active
breast cancer or any other malignancy.
8. Adequate hematologic and end-organ function:
a. Aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) = 2.5 x the
institutional upper limit of normal (ULN)
b. Bilirubin = 1.5 x ULN (except in patients with
previously documented Gilbert’s syndrome, in
which case total bilirubin = 3 x ULN)
c. INR and aPTT = 1.5 x ULN (for patients
requiring therapeutic anticoagulation therapy,
a stable INR = 2,5)
d. Serum creatinine = 1,5 x ULN or creatinine
clearance = 50 ml/min
e. Absolute neutrophil count (ANC) = 1,5 E9/l
f. Platelet count = 100 E9/l
g. Hemoglobin = 100 g/l
9. Willingness to comply with scheduled visits,
laboratory assessments, and other study-related
procedures due to the regulatory requirements related
to gene based therapies.
10. Non-smoker or willing to stop smoking or use of
nicotine-containing products for at least 4 weeks prior
to the study entry.
11. Negative urine pregnancy test (only patients with
childbearing potential) at screening and use of
adequate contraceptive measures from screening until
six months after the study treatment administration:
a) A patient with childbearing potential should be
using a reliable contraception method: combined
(estrogen and progestogen containing) hormonal
contraception associated with inhibition of
ovulation (oral, intravaginal or transdermal,
progestogen-only hormonal contraception
associated with inhibition of ovulation (oral,
injectable or implantable), intrauterine device
(IUD), intrauterine hormone releasing system
(IUS), bilateral tubal occlusion, vasectomised
partner or sexual abstinence defined as refraining
from heterosexual intercourse during the entire
period of risk associated with the study treatments.
b) A male patient is not allowed to donate sperm.??
c) A patient with no current heterosexual relationship
may be included according to the judgement of the
Investigator.
d) For a patient in postmenopausal state neither
contraception nor a pregnancy test is required. A
postmenopausal state is defined as no menses for
12 months without an alternative medical cause. A
high follicle stimulating hormone (FSH) level in
the postmenopausal range may be used to confirm
a postmenopausal state in women not using
hormonal contraception or hormonal

Exclusion Criteria

1. Diagnosed for T4 and/or N2b/N3 stage breast cancer
at the time of the original diagnosis.
2. Evidence (clinical, laboratory or imaging) or history of
a neoplasm other than breast cancer (except basal cell
carcinoma or cervical in situ carcinoma).
3. Diagnosed for metastatic breast cancer.
4. Pregnancy, lactation or a positive or indeterminate
pregnancy test.
5. Current treatment with COX-2 inhibitors should be
interrupted from 2 weeks prior until 4 weeks posttreatment.
6. Previous treatment with, or participation in a trial of a
gene therapy product.
7. Participation in a clinical trial, which has included
interventions in the preceding 6 months or will involve
future interventions. Participation in a noninterventional
clinical trial, or in a non-interventional
follow-up of any clinical trial, does not make the
patient inappropriate for the entry into this study.
8. Current treatment with systemic immunosuppressive
drugs.
9. Current history of drug abuse, including nicotinecontaining
products, or alcohol abuse.
10. Known human immunodeficiency virus- or acquired
immunodeficiency syndrome-related illness.
11. History of hepatic dysfunction, cirrhosis, or hepatitis.
12. Allergy to any ingredients of the Lymfactin® solution
for injection (glycerol, N-2-hydroxyethylpiperazine-
N´-2-ethanesulfonic acid (HEPES), sodium
hydroxide).
13. Other concurrent severe acute and/or chronic medical
or psychiatric condition or laboratory abnormality that
may increase the risk associated with the study
participation or study drug administration, that would,
in the Investigator’s judgement, affect the patient's
ability to follow study-related procedures, or that may
interfere with the interpretation of study results and
would make the patient inappropriate for the entry into
this study.
14. Doubtful availability, in the opinion of the
Investigator, to complete the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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