Overview

Randomized CT to Evaluate Efficacy of Neoadjuvant Chemotherapy Customized by Levels of BRCA1-HER2 Negative Breast Cancer

Status:
Completed
Trial end date:
2016-10-10
Target enrollment:
0
Participant gender:
Female
Summary
Neoadjuvant chemotherapy (NAC) is increasingly used for early-stage operable breast cancer. Response of breast cancer to NAC is correlated with survival: patients who obtain greatest survival advantage are those who attain complete response of their primary tumor. BReast Cancer 1 (BRCA1) plays a crucial role in DNA repair and associations between BRCA1 mRNA expression and sensitivity to platinum and/or resistance to taxanes has been previously documented. We propose a two-arm, randomized, multi-centre, open-label phase II study to compare the efficacy and tolerability of NAC customized by BRCA 1 levels versus standard FEC chemotherapy, being pathological complete response the primary endpoint.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Treatments:
Albumin-Bound Paclitaxel
Cisplatin
Cyclophosphamide
Docetaxel
Epirubicin
Fluorouracil
Paclitaxel
Criteria
Inclusion Criteria:

- Female gender

- 18 years or older

- Performance Status- ECOG: 0-1

- Histologically confirmed invasive breast cancer

- Primary tumor greater than 2 cm diameter

- Any N (0-3)

- No evidence of metastasis (M0), HER-2/ERBb2 negative.

- Known hormone receptors status.

- Haematopoietic status: Absolute neutrophil count > 1.5 x 109/L; Platelet count > 100 x
109/L

- Hemoglobin at least 9 g/dl)

- Hepatic status: Serum total bilirubin < 1.5 x upper limit of normal (ULN), in the case
of known Gilbert's syndrome, a higher serum total bilirubin (< 2 x ULN) is allowed;AST
and ALT < 2.5 times ULN; Alkaline phosphatase < 2.5 times ULN)

- Renal status: Creatinine < 1.5 mg/dl or Cl CR > 60 ml/m

- For women of childbearing potential Negative serum pregnancy test, within 2-weeks
(preferably 7 days) prior to randomization.

- Signed informed consent form (ICF).

Exclusion Criteria:

- Received any prior treatment for primary invasive breast cancer.

- Previous (less than 10 years) or current history of malignant neoplasms, except for
curatively treated:

- Basal and squamous cell carcinoma of the skin;Carcinoma in situ of the cervix.

- Diagnosis of inflammatory breast cancer.

- Known history of uncontrolled or symptomatic angina, clinically significant
arrhythmias, congestive heart failure, transmural myocardial infarction uncontrolled
hypertension (? 180/110), unstable diabetes mellitus, dyspnoea at rest, or chronic
therapy with oxygen.

- Left Ventricular Ejection Fraction of < 50% measured by echocardiography.

- Concurrent disease or condition that would make the subject inappropriate for study
participation or any serious medical disorder that would interfere with the subject?s
safety.

- Unresolved or unstable, serious adverse events from prior administration of another
investigational drug.

- Active or uncontrolled infection.

- Dementia, altered mental status, or any psychiatric condition that would prevent the
understanding or rendering of ICF.

- Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy,
biologic therapy other than the trial therapies).

- Concurrent treatment with an investigational agent or participation in another
therapeutic clinical trial.

- Known immediate or delayed hypersensitivity reaction, idiosyncrasy or contraindication
to drugs chemically related to any of the study treatments or their excipients.

- Pregnant or lactating women.

- Refusal to use contraception throughout the study (surgical sterilization, barrier
methods associated with spermicidal gels or total abstinence). Use of hormonal
contraceptives is not allowed.

- Patient unable to comply with study procedures.