Pathologic Response at Definitive Surgery
Primary
· after 4 cycles of therapy
| Group | Value | 95% CI |
|---|---|---|
| VPA FEC100 | 3 |
Last reviewed · How we verify
NCT01010854: VPA-FEC100
Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Breast Cancer
Terminated
Phase 2
Results posted
Last updated 9 March 2018
What this trial tests
Phase 2 trial testing VPA FEC100 in Breast Cancer in 6 participants. Terminated before completion.
Timeline
10 December 2008
Primary endpoint
12 December 2010
12 December 2010
29 July 2011
Quick facts
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 10 December 2008 |
| Primary completion | 12 December 2010 |
| Estimated completion | 29 July 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
- VPA FEC100 — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
University of California, San Francisco
Who can join
18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Clinical Response Based on Tumor Measurement
Secondary
· after 4 cycles of therapy
| Group | Value | 95% CI |
|---|---|---|
| VPA FEC100 | 3 |
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
VPA FEC100
Serious: 2/6 (33%)
Deaths: 0/6
Serious adverse events (2 terms)
| Reaction | System | VPA FEC100 |
|---|---|---|
| Dizziness | Nervous system disorders | — |
| Febrile Neutropenia | Blood and lymphatic system disorders | — |
Other adverse events (34 terms — click to expand)
| Reaction | System | VPA FEC100 |
|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | — |
| Fatigue | General disorders | — |
| Hair loss/alopecia | Skin and subcutaneous tissue disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | — |
| Lymphopenia | Blood and lymphatic system disorders | — |
| Rigors | General disorders | — |
| Anorexia | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Febrile neutrophenia | Blood and lymphatic system disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Cognitive disturbance | Nervous system disorders | — |
| Dizziness | Nervous system disorders | — |
| Memory impairment | Nervous system disorders | — |
| Anxiety | Psychiatric disorders | — |
| Bone Pain | Musculoskeletal and connective tissue disorders | — |
| Platelets | Blood and lymphatic system disorders | — |
| Insomnia | General disorders | — |
| Thyroid function, low | Endocrine disorders | — |
| Dehydration | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Infection | Blood and lymphatic system disorders | — |
| Alkaline phosphatase | Investigations | — |
| Hypercalcemia | Metabolism and nutrition disorders | — |
| Hypermagnesemia | Metabolism and nutrition disorders | — |
| hypophosphatemia | Metabolism and nutrition disorders | — |
| Agitation | Psychiatric disorders | — |
| Watering Eyes | Eye disorders | — |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | — |
| Breast Pain | Reproductive system and breast disorders | — |
| Headache | Nervous system disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Dizziness, Febrile Neutropenia.
Data from ClinicalTrials.gov NCT01010854 adverse events section.
Sponsor's own description
The drugs FEC 100 (5-fluorouracil, epirubicin, and cyclophosphamide) are one of the approved options to treat Locally Advanced or Primary Metastatic Breast Cancer. In this study, the investigators will add another drug called Valproic Acid (VPA) to see whether this makes the treatment better. The addition of Valproic Acid to chemotherapy has been studied in about 65 subjects with cancer and was found to be safe and tolerable. Valproic Acid is approved by the Food and Drug Administration (FDA) for the treatment of seizures, mood swings, and migraine headaches. It is not currently approved for cancer, which is why the investigators are conducting this study. The results of a Phase I study of Valproic Acid and FEC100 in subjects with cancer that has spread has led the investigators to believe that this combination is better than just the standard treatment alone. The investigators are now testing the combination in a study with subjects who have either a large tumor, many lymph nodes involved or patients whose tumor has spread. In addition to the treatment, a main goal of the study is to find out which subjects will benefit from this combination. In the Phase I trial the investigators noticed that while this combination appears to make the chemotherapy more effective, it did not appear to cause more side effects induced by the chemotherapy.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Combination Therapy With Histone Deacetylase Inhibitors (HDACi) for the Treatment of Cancer: Achieving the Full Therapeutic Potential of HDACi.
Suraweera A, O'Byrne KJ, Richard DJ. · · 2018 · cited 496× · PMID 29651407 · DOI 10.3389/fonc.2018.00092 -
Cancer epigenetics: Moving forward.
Nebbioso A, Tambaro FP, Dell'Aversana C, Altucci L. · · 2018 · cited 325× · PMID 29879107 · DOI 10.1371/journal.pgen.1007362 -
Exploring the Drug Repurposing Versatility of Valproic Acid as a Multifunctional Regulator of Innate and Adaptive Immune Cells.
Soria-Castro R, Schcolnik-Cabrera A, Rodríguez-López G, Campillo-Navarro M, et al · · 2019 · cited 43× · PMID 31001564 · DOI 10.1155/2019/9678098 -
Epigenetics in Breast Cancer Therapy-New Strategies and Future Nanomedicine Perspectives.
Buocikova V, Rios-Mondragon I, Pilalis E, Chatziioannou A, et al · · 2020 · cited 42× · PMID 33287297 · DOI 10.3390/cancers12123622 -
RNA-Seq of human breast ductal carcinoma in situ models reveals aldehyde dehydrogenase isoform 5A1 as a novel potential target.
Kaur H, Mao S, Li Q, Sameni M, et al · · 2012 · cited 34× · PMID 23236365 · DOI 10.1371/journal.pone.0050249 -
Epigenetic Approaches to Overcome Fluoropyrimidines Resistance in Solid Tumors.
Grumetti L, Lombardi R, Iannelli F, Pucci B, et al · · 2022 · cited 10× · PMID 35158962 · DOI 10.3390/cancers14030695
Verify or expand the search:
- PubMed search for NCT01010854
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT01010854 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
- Last refreshed: 9 March 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01010854.
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