Clinical Trials /

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

NCT03712956

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: CAELYX® as Adjuvant Treatment in Early Stage Luminal B Breast Cancer BREAST CANCER
  • Official Title: CAELYX® as Adjuvant Treatment in Early Stage Luminal B Breast Cancer: a Feasibility Phase II Trial

Clinical Trial IDs

  • ORG STUDY ID: IEO 0062
  • NCT ID: NCT03712956

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
Caelyx®CaelyxCaelyx® for 8 courses

Purpose

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.

Detailed Description

      In the 2011 St Gallen Consensus Conference, the Panel considered that both anthracyclines and
      taxanes should be included in the chemotherapy regimen for 'Luminal B' disease1. However,
      several patients are reluctant to receive a "strong" chemotherapy because of the fear of its
      toxic effects, and usually ask for a somehow "less intensive" approach, even accepting a
      possible reduction in the treatment efficacy.

      One of the reasons why patients refuse chemotherapy more often is the fear of alopecia. Few
      dermatologic conditions carry as much emotional distress as chemotherapy-induced alopecia.
      Hair loss negatively affects a patient's perception of appearance, body image, sexuality, and
      self- esteem.

      We decided to conduct 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.

      Secondary endpoints will include:

        -  Adverse events

        -  Tolerability (treatment completion)

        -  Breast cancer free interval (BCFI; events are reappearance of invasive breast cancer at
           any site including contralateral disease)

        -  Disease Free Survival (DFS) (includes second malignancies and deaths)

        -  Overall survival (OS) Caelyx® should be administered intravenously at a dose of 20 mg/m2
           once every two weeks for 8 courses.
    

Trial Arms

NameTypeDescriptionInterventions
Caelyx® for 8 coursesExperimentalCaelyx® administered intravenously at a dose of 20 mg/m2 once every two weeks for 8 courses.
  • Caelyx®

Eligibility 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.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Feasibility of adjuvant PLD (Caelyx®)
Time Frame:4 months
Safety Issue:
Description: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

Secondary Outcome Measures

Measure:Adverse event
Time Frame:4 months
Safety Issue:
Description:Grading for all side effects will be according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measure:percent of patient completing treatment (tolerability)
Time Frame:4 month
Safety Issue:
Description:percent of patients treated according to the protocol and completing the adjuvant program, and percent protocol treatment received
Measure:Breast cancer free interval (BCFI)
Time Frame:5 years
Safety Issue:
Description:BCFI is defined as the time from registration to local (including recurrence restricted to the breast after breast conserving treatment), regional, or distant relapse, or contralateral breast cancer.
Measure:Disease Free Survival (DFS)
Time Frame:5 years
Safety Issue:
Description:DFS is defined as the time from registration to disease recurrence (includes second malignancies and deaths)
Measure:Overall survival (OS)
Time Frame:5 years
Safety Issue:
Description:OS defined as the time from registration to death from any cause

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:European Institute of Oncology

Trial Keywords

  • early breast cancer
  • luminal B
  • adjuvant chemotherapy

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