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Breast CancerPhase 2NCT03712956

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

A Phase 2 study testing Caelyx® in people with Breast Cancer, run by European Institute of Oncology at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Caelyx®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteItaly
Study dates
25 Mar 2016to 31 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 32Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • European Institute of Oncology

    Milan

Other trials in Italy

About this study

Official title: CAELYX® as Adjuvant Treatment in Early Stage Luminal B Breast Cancer: a Feasibility Phase II Trial

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.

Read the 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.
Conditions
Breast Cancer
Being tested
Caelyx®
Keywords
early breast cancer, luminal B, adjuvant chemotherapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caelyx®Drug

    Also called Caelyx

    Caelyx® every two weeks for 8 courses

Study groups in NCT03712956
Study groupRoleWhat they receive
Caelyx® for 8 coursesExperimentalCaelyx® administered intravenously at a dose of 20 mg/m2 once every two weeks for 8 courses.
Receives: Drug: Caelyx®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of adjuvant PLD (Caelyx®)

    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

    Measured: 4 months

Secondary outcomes (5)

  1. Adverse event

    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

    Measured: 4 months

  2. percent of patient completing treatment (tolerability)

    percent of patients treated according to the protocol and completing the adjuvant program, and percent protocol treatment received

    Measured: 4 month

  3. Breast cancer free interval (BCFI)

    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.

    Measured: 5 years

  4. Disease Free Survival (DFS)

    DFS is defined as the time from registration to disease recurrence (includes second malignancies and deaths)

    Measured: 5 years

  5. Overall survival (OS)

    OS defined as the time from registration to death from any cause

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2018
  2. Study start25 Mar 2016
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03712956
Sponsor's protocol ID
IEO 0062
Status last verified
May 2023
First submitted
25 Sep 2018
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Caelyx® in people with Breast Cancer, run by European Institute of Oncology at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of adjuvant PLD (Caelyx®) (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03712956.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

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