A Phase 1 interventional study of POL6326 in Metastatic Breast Cancer, sponsored by Polyphor Ltd.. Completed at 12 sites in 2 countries. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-09-14.
Sponsored by Polyphor Ltd. · Phase 1, Interventional, and Treatment
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Among 905 studies in Breast Neoplasms with a site in Spain — 164 open to participants now, 286 under way, 84 of them phase 3. Breast Neoplasms · Spain.
Among the 905 studies in Breast Neoplasms with a site in Spain, this one is the 635th largest by enrollment of the 805 interventional ones that give a count, is one of 46 that started in 2013, is one of 104 in phase 1, and was the 268th registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
Browse Breast Neoplasms studies →164 of the 905 studies in Breast Neoplasms with a site in Spain are open now. Recruiting first, the newest first:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Sites in Spain
Ages 18+
Spanish Breast Cancer Research Group · Sites in Spain
Ages 18+
Daiichi Sankyo · Sites in Spain, United States, Belgium and 5 more countries
Ages 18+
Kenko Imalytics S.L. · Sites in Spain
Ages 18+ · Women only
Spanish Breast Cancer Research Group · Sites in Spain
Ages 18+ · Women only
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years to 55 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
905 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 174 · Phase 2 326 · Phase 3 224 · Phase 4 13
First in 1996; this study’s year is marked. 46 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 54 is below the median of 72 across 10,900 interventional studies indexed under Breast Neoplasms.
Median enrollment 151 across the 805 interventional studies, 200 across the 97 observational. Of the 575 that completed or were terminated, 291 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
533 of 905 have an industry lead sponsor. The 10 most frequent:
Polyphor Ltd. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Polyphor Ltd. has 1 study filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
81 of the studies in Breast Neoplasms with a site in Spain that are under way reach primary completion within a year, 21 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646862Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | 2026-11-13 |
| NCT03820830Phase 3ETOP IBCSG Partners FoundationPalbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer | 2026-12 |
| NCT03595592Phase 3Fondazione MichelangeloNeoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer | 2026-12-15 |
| NCT05909397Phase 3PfizerVepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer | 2026-12-30 |
| NCT05894239Phase 3Hoffmann-La RocheA Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer | 2026-12-31 |
Add all 81 to your calendar (.ics) → With an account.
Among the 905 studies in Breast Neoplasms with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin. Different doses and dosing frequencies will be investigated
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin
Drug: POL6326
POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin
Safety and tolerability of POL6326 in combination with eribulin in patients with metastatic breast cancer
Incidence and severity of adverse events and serious adverse events of the combination of POL6326 and eribulin when compared to the adverse event profile of eribulin alone
Time frame: 6 months
Response rate of treatment with POL6326 and eribulin in patients with metastatic breast cancer
Determination of the complete response (CR) and partial response (PR) in patients treated with the combination of POL6326 and eribulin
Time frame: 12-24 months
The record gives a start of Jun 2013, a primary completion of Aug 2018 and a completion of Aug 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Balixafortide
Polyphor Ltd.