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A Phase II Study of Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Locally Advanced or Primary Metastatic Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Phase II Study of Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Locally Advanced or Primary Metastatic Breast Cancer

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.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed diagnosis of breast

- Patients must have "locally advanced" adenocarcinoma of the breast:

- tumors > 2 cm without lymph node involvement (negative sentinel lymph node

- 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

- tumors of any size associated with ipsilateral internal mammary nodes (stage

- 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

- 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

Exclusion Criteria:

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic response at definitive surgery

Outcome Time Frame:

after 4 cycles of theray

Safety Issue:


Principal Investigator

Pamela Munster, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:

CC# 087515



Start Date:

December 2008

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • breast cancer
  • advanced
  • local
  • Breast Neoplasms



University of California San FranciscoSan Francisco, California  941104206