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-CZ
• Lead Sponsor: Polyphor Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-14
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• 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 prior to the start of study medication.
13. Must be willing an

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