A clinical study to compare treatment of Balixafortide in combination with Eribulin or Eribulin alone, in patients with no protein HER2 present in their cells and had locally repeated or spread breast cancer.

Phase 1

• Conditions: Patients with HER2 negative, Locally Recurrent or Metastatic Breast Cancer; MedDRA version: 20.0Level: PTClassification code 10006198Term: Breast cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004211-42-GB
• Lead Sponsor: Polyphor Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-25
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 384

Inclusion Criteria

1. Patients at least 18 years of age (or according to local regulation)
2. Documented histologically confirmed BC.
3. Metastatic BC currently of stage IV disease by American Joint
Committee on Cancer criteria or unresectable locoregionally recurrent
BC.
4. Molecular status and prior therapies:
a) Molecular Status
Eligible patients are, by their patient records and prior therapy, HER2 negative with any ER or PgR status. If a previous record of the HR status
is not available, the HR status should be tested locally.
HER2 negative (immunohistochemistry [IHC] 0,1 or fluorescence in situ
hybridization [FISH] or chromogenic in situ hybridization [CISH]
HER2:CEP17 ratio < 2.0); HER2 2+ patients should be ISH/CISH
negative.
b) Prior Therapies Patients with locally recurrent or metastatic BC who
have previously received 1-4 chemotherapeutic regimens for the
treatment of locally recurrent or metastatic BC. Unless contra-indicated
for safety reasons, prior therapy will have included an anthracycline and
a taxane in either the adjuvant or metastatic setting.
Patients with HR positive status (ER+ and/or PgR+) must have been
treated with at least one line of endocrine therapy and considered by the
treating physician not to be a candidate for further endocrine therapy.
5. At least 14 days from the completion of any previous cytotoxic
chemotherapy, biological therapy, or any other investigational agent at
time of initiation of study medication. Resolution of chemotherapy and
radiation therapy related toxicities to Grade 1 or lower severity, except
for stable sensory neuropathy Grade 2 or lower and alopecia.
6. Patients must have proved refractory to the most recent
chemotherapy, documented by progression on or within six (6) months
of therapy.
7. Females of child bearing potential must be willing and able to use
highly effective contraception (as described in the protocol) whilst they
or their male partners are on this study from randomization until 3
months after the last dose of study medication (Section 5.4.5). Male
patients must commit to using an approved form of birth control
(including double-barrier contraception [e.g. consistent and correct use
of male condom with diaphragm or male condom with cervical cap] or
sterilization method) whilst on treatment and for 3 months after the last
dose of study medication (Section 5.4.5).
8. ECOG performance status of 0-2.
9. Life expectancy of 3 months or more as per Investigator assessment.
10. Adequate organ function defined at Screening as:
a) White blood cell (WBC) =3000/mm3.
b) Absolute neutrophil count (ANC) =1500/mm3.
c) Platelets =75000/mm3.*
* =100000/mm3 in France
d) Creatinine Clearance =30 mL/minute as calculated by the Cockcroft-
Gault equation
or serum creatinine <1.5x institutional upper limit of normal (ULN).
e) Total bilirubin =1.5x institutional ULN; aspartate aminotransferase
(AST), alanine aminotransferase (ALT) =3x institutional ULN (for
patients with liver metastases, =5x ULN).
f) Hemoglobin =10 g/dL.
11. Patients who have central nervous system involvement if metastases
have been treated and are stable for at least 4 weeks after completion of
radiation therapy and/or surgery.
Stable is defined as the absence of the need for dexamethasone or other
corticosteroid therapy, and radiographic confirmation of SD.
12. Patients receiving bone-modifying agents (BMA [bisphosphonates or
denosumab]) if BMA was initiated at least 4 weeks pri

Exclusion Criteria

1. Previously received eribulin.
2. Peripheral neuropathy Grade =3.
3. Receipt of prior CXCR4 therapy.
4. Receipt of colony stimulating factors (CSFs) filgrastim, pegfilgrastim,
or sargramostim within 14 days prior to time of initiation of study
medication.
5. Radiation therapy within 14 days prior to time of initiation of study
medication.
6. Severe concurrent illness or psycho-social situation that would limit
compliance with study requirements or that, in the Investigator's
opinion, would preclude enrolment.
7. History of allergic reactions attributed to compounds of similar
chemical or biologic composition to balixafortide or eribulin, or known
intolerance to balixafortide or eribulin.
8. Breast feeding or pregnant, as determined by a serum pregnancy test
beta human chorionic gonadotrophin (ß-HCG) at Screening and prior to
the administration of study medication.
9. Patients with congestive heart failure, electrolyte abnormalities,
bradyarrhythmias, known congenital long QT syndrome, QT interval
corrected with Fridericia's formula (QTcF) =470 msec at baseline in the
absence of bundle branch block, or currently taking drugs at known risk
of prolonging the QT interval or causing torsades de pointes (including
Class Ia and III anti-arrhythmic drugs; see also Appendix 1 Prohibited
Medications).
Patients with hypokalemia or hypomagnesemia should not be
randomized until the hypokalemia or hypomagnesemia is corrected.
10. Patients with a concurrent malignancy or malignancy 2 years prior to
randomization with the exception of adequately treated basal and
squamous cell carcinoma, non-melanomatous skin cancer, or curatively
resected cervical cancer.
11. Persons who have been housed in an institution due to a government
or judicial order (applicable to Germany only).

Study & Design

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