Overview

CAELYX® as Adjuvant Treatment in Early Stage Luminal B Breast Cancer BREAST CANCER

Status:
Active, not recruiting
Trial end date:
2021-03-25
Target enrollment:
0
Participant gender:
Female
Summary
A single-center, phase II, single-arm, feasibility study to evaluate PLD (Caelyx®) as an adjuvant chemotherapy regimen in patients with early-stage luminal B breast cancer. The primary endpoint will be to evaluate the feasibility of adjuvant PLD (Caelyx®) for each individual subject. The regimen will be considered feasible if that subject is able to achieve relative dose intensity (RDI) of at least 85% of the 8 cycles of treatment. Caelyx® should be administered intravenously at a dose of 20 mg/m2 once every two weeks for 8 courses.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
European Institute of Oncology
Collaborator:
Janssen-Cilag International NV
Treatments:
Doxorubicin
Liposomal doxorubicin
Phenobarbital
Criteria
Inclusion Criteria:

- Performance status (ECOG) 0-2

- Operable histologically confirmed breast cancer

- Luminal B HER2-negative (ER positive, HER2 negative, and at least one of the
following:

Ki- 67 'high' (≥20%) or PgR 'negative or low') or Luminal B HER2-positive (ER positive,
HER2 over-expressed or amplified, any Ki-67, any PgR)

- Early-stage (pT1-3; any nodal status)

- Candidate to adjuvant chemotherapy and endocrine therapy

- The tumor must be confined to the breast and axillary nodes without detected
metastases elsewhere

- Patients with synchronous (diagnosed histologically within 2 months) bilateral
invasive breast cancer are eligible if all other criteria are met

- Patients must have had surgery for primary breast cancer with no known clinical
residual loco-regional disease

- Margins must be negative for invasive breast cancer and DCIS

- Patients should start treatment as close to definitive surgery as possible (no later
than 8 weeks)

- No prior neoadjuvant or adjuvant therapy for breast cancer. Note: Radiotherapy is
allowed prior to trial entry. Raloxifene, tamoxifen, or other SERM must be
discontinued at least 4 weeks before trial entry.

- No hormone replacement therapy (HRT)

- No hormonal therapy, except steroids for adrenal failure, hormones for non-breast
cancer related conditions (e.g., insulin for diabetes), or intermittent dexamethasone
as an antiemetic.

- No treatment with bisphosphonates, except for the treatment of osteoporosis

- Adequate bone marrow, renal, and hepatic function must be assessed within 2 months
before trial entry and values must meet the following criteria:

- WBC ≥ 3.0 x 109/L

- Granulocyte count ≥ 1.500 x 109/L

- Hemoglobin ≥ 10.0 g/dL

- Platelet count ≥ 100 x 109/L

- Serum creatinine < 1.35 mg/dl - Calculated creatinine clearance at least 50 mL/min

- Serum bilirubin within normal/reference range

- AST/ALT within 1.5 x upper normal limit

- Adequate cardiovascular function defined as the following must be assessed within
2 months before trial entry:

- LVEF ≥ 50% by echocardiography, radionuclide ventriculography or Multigated
Angiography (MUGA) - No ECG evidence of acute ischemia

- No evidence of medically relevant conduction system abnormalities, which in the
opinion of the investigator would preclude trial entry

- No myocardial infarction within the past 6 months

- No New York Heart Association (NYHA) class III or IV congestive heart failure

- Negative pregnancy test (in fertile women).

- Written Informed Consent (IC) must be signed and dated by the patient and the
investigator prior to trial entry.

- Patients must be accessible for follow-up.

- Patients should have no psychiatric, addictive, or cognitive disorder that would
prevent compliance with protocol requirements.

Exclusion Criteria:

- Patients with a history of any prior ipsilateral or contralateral invasive breast
cancer.

- Patients with previous or concomitant malignancy diagnosed within the past five years.
Patients with adequately treated basal or squamous cell carcinoma of the skin, in situ
carcinoma of the cervix or bladder, contra- or ipsilateral in situ breast carcinoma
are eligible regardless of the date of diagnosis.

- Patients with other non-malignant uncontrolled systemic diseases that would preclude
trial entry in the opinion of the investigator. Specifically not eligible are patients
with uncontrolled active infection, chronic infection such as active HBV or HCV.

- Patients with myocardial infarction or pulmonary embolism within 6 months prior to
trial entry.