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Trial record 10 of 2026 for:    doxil

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

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ClinicalTrials.gov Identifier: NCT03712956
Recruitment Status : Active, not recruiting
First Posted : October 19, 2018
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
Janssen-Cilag International NV
Information provided by (Responsible Party):
European Institute of Oncology

Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Caelyx® Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CAELYX® as Adjuvant Treatment in Early Stage Luminal B Breast Cancer: a Feasibility Phase II Trial
Actual Study Start Date : March 25, 2016
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Caelyx® for 8 courses
Caelyx® administered intravenously at a dose of 20 mg/m2 once every two weeks for 8 courses.
Drug: Caelyx®
Caelyx® every two weeks for 8 courses
Other Name: Caelyx




Primary Outcome Measures :
  1. Feasibility of adjuvant PLD (Caelyx®) [ Time Frame: 4 months ]
    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 :
  1. Adverse event [ Time Frame: 4 months ]
    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

  2. percent of patient completing treatment (tolerability) [ Time Frame: 4 month ]
    percent of patients treated according to the protocol and completing the adjuvant program, and percent protocol treatment received

  3. Breast cancer free interval (BCFI) [ Time Frame: 5 years ]
    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.

  4. Disease Free Survival (DFS) [ Time Frame: 5 years ]
    DFS is defined as the time from registration to disease recurrence (includes second malignancies and deaths)

  5. Overall survival (OS) [ Time Frame: 5 years ]
    OS defined as the time from registration to death from any cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712956


Locations
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Italy
European Institute of Oncology
Milan, Italy
Sponsors and Collaborators
European Institute of Oncology
Janssen-Cilag International NV
Investigators
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Principal Investigator: Elisabetta Munzone, MD European Institute of Oncology

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Responsible Party: European Institute of Oncology
ClinicalTrials.gov Identifier: NCT03712956     History of Changes
Other Study ID Numbers: IEO 0062
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by European Institute of Oncology:
early breast cancer
luminal B
adjuvant chemotherapy
Additional relevant MeSH terms:
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Liposomal doxorubicin
Doxorubicin
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Phenobarbital
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers