A study investigating the use of additional chemotherapy for the improvement of efficacy, and the selection of breast cancer patients for such treatment in two paitent cohorts: Before surgery in curable patients and at time of metastatic disease.

Phase 1

• Conditions: breast cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004418-17-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-26
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Cohort I: Patients with large (radiologic measureable tumor > 2.0 cm) HER2 negative mammary carcinomas in the following categories are eligible for inclusion into the study:
•T2 tumors with:
o Ki67 labeling index = 20%
or
oER positive and Progesterone receptor negative status
or
ograde 3 tumors
•T3-T4 tumors with Ki67 = 15%.
The patients should not have received previous treatment for the current disease and should be without signs of metastatic disease as determined by liver ultrasound or CT scan and bone scintigraphy or MRI.

Cohort II: Patients with evaluable metastatic disease from breast carcinoma according to the RECIST criteria, AND elegible for biopsy of the metastatic tumor for diagnosis and research purposes before, during and after therapy.

1. Written informed consent obtained prior to any study-specific procedure
2. Female or male age ?18 years
3. Able to comply with the protocol
4. Histologically or cytologically confirmed, HER2-negative, men or women with breast
adenocarcinoma
5. WHO performance status = 2
6. Adequate hematological function
Absolute neutrophil count (ANC) =1.0 x 109/L
AND
Platelet count =100 x 109/L
AND
Hemoglobin = 10 g/dL (may be transfused to maintain or exceed this level)
7. Adequate liver function
Total bilirubin <1.5 x upper limit of normal (ULN)
AND
AST, ALT <2.5 x ULN (in cohort I)
AST, ALT <5 x ULN (in cohort II)
8. Adequate renal function
Serum creatinine =1.25 x ULN or calculated creatinine clearance =50 mL/min
9. Normal baseline cardiac function (LVEF) as measured by MUGA or ECHO
10. Women should not be pregnant or breast-feeding. Women with an intact uterus
(unless amenorrhoeic for the last 24 months and premenopausal levels of FSH, LH
and oestradiol) must have a negative serum pregnancy test within 28 days prior to
inclusion into the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Previous chemotherapy treatment for localized breast cancer less than 24 months before inclusion into study (cohort I) or metastatic breast cancer treated with taxane (cohort II).
2. Other earlier or concomitant carcinoma less than five years prior to the breast cancer diagnosis, except for BCC, in situ cervix cancer or breast cancer
3. Clinically significant (i.e. active) cardiovascular disease for example CVA (=6 months before enrolment), myocardial infarction (=6 months before enrolment), unstable angina, congestive heart failure (CHF) NYHA Class =II, serious cardiac arrhythmia requiring medication during the study, which might interfere with regularity of the study treatment, or not controlled by medication
4. Treatment with any other investigational agent, or participation in another clinical intervention trial within 21 days prior to enrolment
5.Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified