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Breast NeoplasmsPhase 1NCT04522557

Type I Interferon Alfa-2a in Postmastectomy Breast Reconstruction

A Phase 1 study testing IFNα-2a in people with Breast Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Implant-based reconstruction have become the most popular choices of reconstruction for women undergoing breast mastectomy. Postoperative complications like infection and tumor recurrence limit its application. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
IFNα-2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteChina
Study dates
6 Aug 2020to 14 Jul 2021
Phase
Phase 1
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

  • Signed the informed consent.
  • Female aged between 18 and 70 years.
  • Pathologically diagnosed operable breast cancer.
  • WHO Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Newly diagnosed breast cancer.
  • The important organ functions meet the following criteria:
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  • WBC >=3.0 x 10^9/L; Neutrophilic granulocytes >=1.5×10^9/L; Platelet >=100 x 10^9/L; Hb >=9 g/dL;
  • Total bilirubin no more than 1.5 times the normal upper limit (ULN); AST and ALT no more than 1.5 times ULN; AKP no more than 2.5 times ULN;
  • Serum creatinine no more than 1.5 times ULN or Clearance rate of creatinine >= 60ml/min;
  • Thyroid stimulating hormone (TSH) <= ULN (T3, T4 levels need to be detected simultaneously if abnormalities, the patient can be included if T3, T4 levels is normal);
  • LVEF basement >= 50%.

Who cannot join

  • Evidence of distant metastasis.
  • Any contraindication of nipple-areolar complex (NAC) saving mastectomy (NSM):
  • Intraoperative biopsy revealed carcinoma invasion of NAC.
  • Paget's disease of breast.
  • Tumor distant from NAC less than 1 cm.
  • Any invasive malignancy diagnosed within previous 5 years (other than successfully treated cervical carcinoma in situ, skin basal cell carcinoma or cutaneous squamous cell carcinoma).
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  • At least 4 months since prior interferon therapy.
  • At least 3 weeks since prior major surgery requiring general anesthesia.
  • At least 3 weeks since prior radiotherapy or chemotherapy.
  • Hypersensitivity to interferon or other components: urticaria, angioedema, bronchial stenosis, anaphylaxis, or Stevens-Johnson syndrome.
  • Prior organ allograft.
  • Use of an unlicensed or other investigational drug within 4 weeks.
  • Any severe comorbidities, inability to give informed consent or unavailability for follow-up, including but not limited to any of the following:
  • Heart failure above NYHA class 2 level; high-risk uncontrollable arrhythmia; unstable angina pectoris; myocardial infarction within 1 intervention.
  • Chronic obstructive pulmonary disease requires treatment.
  • Chronic liver disease (cirrhosis, chronic active hepatitis, etc.).
  • Cerebrovascular accident occurred within 6 months.
  • Severe epilepsy or central nervous system diseases.
  • Hypertension which cannot be well controlled by antihypertensive drugs.
  • Abnormal coagulation, bleeding tendency, or receiving thrombolysis or anticoagulant therapy.
  • Chronic renal insufficiency.
  • Active infection.
  • Psychiatric disability, etc.
  • Pregnant or lactating women.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shicheng Su

    Guangzhou, Guangdong, 510120

Other trials in China

About this study

RATIONALE: Implant-based reconstruction have become the most popular choices of reconstruction for women undergoing breast mastectomy. Postoperative complications like infection and tumor recurrence limit its application. Interferons (IFNs) are pleiotropic cytokines that involve in immunoregulatory, anticancer and restricting infection. Especially, type I IFN signaling is reported favourable for the success of conventional chemotherapeutics, radiotherapy and immunotherapy. In addition, type I IFN can regulate the activity of almost all immune cell types (including T cells, macrophages and innate lymphocytes), creating a well-established immune environment to defense infectious and relapsing disease. Implants are rapidly coated with extracellular matrix proteins and immune protein components for the formation of a typical capsule. At the specific time point before implantation, the locally utilized of IFN in intracavity breast is assumed to modify cellular immune responses thus contributing to decreasing infection and tumor recurrence.

PURPOSE: This non-randomized phase I trial aims to explore dose range of IFNα-2a. Adverse events are observed to assess drug safety and human tolerance index.

Being tested
IFNα-2a
Keywords
Breast reconstruction, Implants, Interferon (IFN)
Medical subject headings
Breast Neoplasms

What participants receive

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

  • IFNα-2aDrug

    After mastectomy, it is used in the cavity of breast before conducting implantation.

Study groups in NCT04522557
Study groupRoleWhat they receive
Experimental: Participants with breast cancer enrolled in grouExperimentalNot described
Receives: Drug: IFNα-2a

What is being measured

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

  1. Dose-limiting toxicity (DLT)

    Dose-limiting toxicity (DLT), defined as certain grade II toxicity such as nephrotoxicity and cardiotoxicity, grade III non-hematologic toxicity and grade IV hematologic toxicity.

    Measured: 7 days after surgery

  2. Maximal tolerable dose (MTD)

    Maximal tolerable dose (MTD), defined as a dose level where 2 or more subjects among 6 subjects suffering DLT. If the experiment reached the set maximum dose without any DLT occurring, the maximum dose was defined as MTD.

    Measured: 7 days after surgery

Secondary outcomes (2)

  1. Adverse events (AE)

    Measured: 7 days after surgery

  2. Server adverse events (SAE)

    Measured: 7 days after surgery

Timeline

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

  1. First posted21 Aug 2020
  2. Study start6 Aug 2020
  3. Primary completion14 Jul 2021
  4. Study completion14 Jul 2021

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04522557
Sponsor's protocol ID
2020-KY-051
Status last verified
Feb 2022
First submitted
18 Aug 2020
Last updated
9 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IFNα-2a in people with Breast Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

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 11 inclusion and 24 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: finished, as of the sponsor's last update on 9 Feb 2022. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Dose-limiting toxicity (DLT) (time frame: 7 days after surgery). The study lists 2 primary outcomes in all. 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 NCT04522557.

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 9 Feb 2022.

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