Breast CancerPhase 2VPA-FEC100NCT01010854
Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Breast Cancer
A Phase 2 study testing VPA FEC100 in people with Breast Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- VPA FEC100
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2008to 29 Jul 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed diagnosis of breast cancer
- Patients must have "locally advanced" adenocarcinoma of the breast:
- tumors > 2 cm without lymph node involvement (negative sentinel lymph node mapping)
- tumors > 2 cm with lymph node involvement (either by positive sentinel lymph node mapping or FNA of palpable lymph node)
- tumors of any size that show extension to the chest wall or skin, including edema, ulceration, or satellite skin nodules
- inflammatory carcinoma (stage IIIB) that is amenable to surgery
Show all 21Show fewer
- tumors of any size associated with ipsilateral internal mammary nodes (stage IIIB)
- tumors of any size associated with ipsilateral supraclavicular lymph nodes (IIIC) without other evidence of systemic metastases
- patients may have bilateral breast cancer if both breasts are assessible for response
- Age >18 years
- Because no dosing or adverse event data are currently available on the use of VPA in combination with FEC100 in patients <18 years of age, children are excluded from this study
- ECOG performance status 0 or 1 (Karnofsky >80%)
- Patients must have normal organ and marrow function as defined below:
- leukocytes >3,000/mcL
- absolute neutrophil count >1,500/mcL
- platelets >100,000/mcL
- total bilirubin within 1.5 x normal institutional limits
- AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
- Creatinine within normal institutional limits
- VPA has been associated with neural tube defects in the developing human fetus, for this reason and because FEC100 used in this trial are also known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Participating men must use condoms while on study and for at least 3 months after the trial has ended. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients may not have had any prior chemotherapy within the last 2 years
- Patients may not have been exposed to prior anthracyclines
- Patients may not be receiving any other investigational agents
- Patients with known brain metastases are excluded
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to VPA or FEC100.
- Patients with known congestive heart disease or LVEF fractions of <50 % (past or current), patients with known ventricular arrhythmias
Show all 9Show fewer
- Patients taking VPA as an anti-seizure agent or for any other indications
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Due to the teratogenic effects of VPA and FEC100, pregnant or lactating women are excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94115
About this study
Official title: A Phase II Study of Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Locally Advanced or Primary Metastatic Breast Cancer
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.
Read the detailed description
Each year, more than 200,000 patients are diagnosed with breast cancer. While recent advances in diagnosis and treatment have rendered a large proportion of these patients curable, many patients still present with either locally advanced or metastatic breast cancer that is not amenable to potentially curative surgery. To enhance the chance of complete surgical resection of the tumor, patients with very large, locally advanced or inflammatory breast cancer will be offered neo-adjuvant therapy.
The use of systemic chemotherapy after the surgical therapy for patients with operable disease has been associated with a 25%-35% reduction in the risk of systemic relapse (Early Breast Cancer Trialists' Collaborative Group, 1998) Administration of chemotherapy prior to surgery, also referred to as neoadjuvant chemotherapy is often used in patients with inoperable, non-metastatic breast cancer. However more recently, neoadjuvant therapy has become more commonly used as it allows the direct assessment of response to systemic therapy and the collection of biological markers of therapy that are otherwise difficult to obtain. Furthermore, the relative high response rate allows the ability to surgically remove the tumor and achieve adequate tumor-free margins.
- Conditions
- Breast Cancer
- Being tested
- VPA FEC100
- Keywords
- breast cancer, advanced, local
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPA FEC100Drug
oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)
| Study group | Role | What they receive |
|---|---|---|
| VPA FEC100 | Experimental | Valproic Acid with FEC100 Receives: Drug: VPA FEC100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Response at Definitive Surgery
Measured: after 4 cycles of therapy
Secondary outcomes (1)
Clinical Response Based on Tumor Measurement
Measured: after 4 cycles of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study start10 Dec 2008
- Primary completion12 Dec 2010
- Study completion29 Jul 2011
Why it stopped: Premature closure for lack of efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
- Responsible party
- Sponsor
- Investigators
- Pamela Munster, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010854
- Sponsor's protocol ID
- CC# 087515
- Acronym
- VPA-FEC100
- Status last verified
- Feb 2018
- First submitted
- 6 Nov 2009
- Last updated
- 9 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Locally Advanced or Primary Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01010854
- Acronym / sponsor ID
- VPA-FEC100 / CC# 087515
- Conditions
- Breast Cancer
- Keywords
- breast cancer, advanced, local
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Premature closure for lack of efficacy.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
- Study start
- 10 Dec 2008 (actual)
- Primary completion
- 12 Dec 2010 (actual)
- Study completion
- 29 Jul 2011 (actual)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Posted 9 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Each year, more than 200,000 patients are diagnosed with breast cancer. While recent advances in diagnosis and treatment have rendered a large proportion of these patients curable, many patients still present with either locally advanced or metastatic breast cancer that is not amenable to potentially curative surgery. To enhance the chance of complete surgical resection of the tumor, patients with very large, locally advanced or inflammatory breast cancer will be offered neo-adjuvant therapy.
The use of systemic chemotherapy after the surgical therapy for patients with operable disease has been associated with a 25%-35% reduction in the risk of systemic relapse (Early Breast Cancer Trialists' Collaborative Group, 1998) Administration of chemotherapy prior to surgery, also referred to as neoadjuvant chemotherapy is often used in patients with inoperable, non-metastatic breast cancer. However more recently, neoadjuvant therapy has become more commonly used as it allows the direct assessment of response to systemic therapy and the collection of biological markers of therapy that are otherwise difficult to obtain. Furthermore, the relative high response rate allows the ability to surgically remove the tumor and achieve adequate tumor-free margins.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VPA FEC100 | Experimental | Drug: VPA FEC100Valproic Acid with FEC100 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must have histologically or cytologically confirmed diagnosis of breast cancer
- Patients must have "locally advanced" adenocarcinoma of the breast:
- Age >18 years
- Because no dosing or adverse event data are currently available on the use of VPA in combination with FEC100 in patients <18 years of age, children are excluded from this study
- ECOG performance status 0 or 1 (Karnofsky >80%)
Key exclusion criteria (9 listed)
- Patients may not have had any prior chemotherapy within the last 2 years
- Patients may not have been exposed to prior anthracyclines
- Patients may not be receiving any other investigational agents
- Patients with known brain metastases are excluded
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to VPA or FEC100.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VPA FEC100oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2) | Drug | VPA FEC100 |
Primary outcome
Pathologic Response at Definitive Surgery
Time frame: after 4 cycles of therapy
1 secondary outcome
Clinical Response Based on Tumor Measurement
Time frame: after 4 cycles of therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Munster, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VPA FEC100 in people with Breast Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Response at Definitive Surgery (time frame: after 4 cycles of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.