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Breast CancerPhase 2GIADANCT04659551

Neoadjuvant Chemo-endocrine Therapy and Immunotherapy for Pre-menopausal Luminal B Breast Cancer Patients

A Phase 2 study testing Epirubicin, Cyclophosphamide and Triptorelin in people with Breast Cancer, run by Istituto Oncologico Veneto IRCCS at 5 sites in Italy.

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

Multicentric, phase II neoadjuvant trial in hormone-positive, HER-negative, luminal B, premenopausal breast cancer patients stage II-IIIA. Patients receive as neoadjuvant treatment before surgery: three courses of anthracycline-based chemotherapy followed by exemestane p.o. daily plus nivolumab i.v. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Epirubicin, Cyclophosphamide and Triptorelin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
5 sitesItaly
Study dates
5 Oct 2017to 25 May 2020
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients may be included in the study only if they met all the following criteria
  • age >18 yrs
  • female patients
  • ECOG Performance Status 0-1
  • must have signed and dated an IRB/IEC-approved written informed consent form in accordance with regulatory and institutional guidelines before the performance of any protocol-related procedures
  • Primary diagnosis of invasive breast cancer, HR positive (ER ≥ 10% and/or PgR ≥10% by IHC) and HER2 negative (IHC 0/1+ and/or FISH/CISH negative) according to local assessment.
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  • Histologic grade 3 and/or Ki67 >20% according to local assessment.
  • Stage II-IIIA
  • Eligible for neoadjuvant chemotherapy according to multidisciplinary evaluation.
  • Premenopausal status
  • Normal organ and marrow function
  • Availability of tumor tissue suitable for biological and molecular examination before starting primary treatment
  • Ability to understand and willingness to sign a written informed consent document

Who cannot join

  • Patients will be excluded from the study for any of the following reasons
  • Stage IIIB, IIIC, and inflammatory breast cancer
  • Stage IV breast cancer
  • Prior treatment with chemotherapy, biologic therapy, endocrine therapy or radiotherapy for the treatment of the newly-diagnosed breast cancer.
  • Contraindication to anthracycline-based chemotherapy.
  • Received any investigational treatment within 4 weeks of study start.
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  • Any other concurrent chemotherapy, biologic therapy, endocrine therapy or radiotherapy for cancer treatment.
  • Known HIV, HBV, HCV infection or any positive tests for HBV and HCV indicating acute or chronic infection.
  • Known severe hypersensitivity to any of the study drugs or excipients or known severe hypersensitivity reactions to monoclonal antibodies.
  • Major surgical procedure or significant traumatic injury within 28 days prior to treatment initiation or anticipation of need for major surgery during the course of study treatment.
  • History of allogenic organ transplantation
  • Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident /stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication.
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of treatment initiation.
  • Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject's ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study results.
  • Prisoners or subjects who are involuntarily incarcerated
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
  • Lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medication.
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
  • Current pregnancy and/or lactation.
  • Refusal to adopt adequate (highly effective) contraception methods.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Italy5 sites

  • Centro di Riferimento Oncologico di Aviano (CRO)

    Aviano, PN

  • Arcispedale S. Anna

    Cona, FE

  • Istituto Oncologico veneto IRCCS

    Padova, 35128

  • Azienda Ospedaliera Universitaria di Parma

    Parma, PR, 43126

  • Arcispedale S. Maria Nuova

    Reggio Emilia, RE

Other trials in Italy

About this study

Official title: Engaging the Immune System to Improve the Efficacy of Neoadjuvant Chemo-endocrine Therapy for Premenopausal Luminal B Breast Cancer Patients

Multicentric, phase II neoadjuvant trial in hormone-positive, HER-negative, luminal B, premenopausal breast cancer patients stage II-IIIA. Patients receive as neoadjuvant treatment before surgery: three courses of anthracycline-based chemotherapy followed by exemestane p.o. daily plus nivolumab i.v. 2-weekly for 8 courses. GnRH analogues are started concomitantly with chemotherapy and maintained until the completion of neoadjuvant treatment.

Read the detailed description

This is a multicenter, phase II neoadjuvant trial in hormone-sensitive, HER-negative, luminal B, premenopausal breast cancer patients stage II-IIIA.

Patients will undergo a core-biopsy of the primary tumor, for the histological diagnosis and the biological characterization of the tumor.

After confirmation of eligibility and informed consent signature, the patients will start neoadjuvant treatment including:

Epirubicin 90 mg/mq + Cyclophosphamide 600 mg/mq i.v. every 3 weeks for 3 courses, followed by the combination of Nivolumab (240 mg flat dose i.v. each 2 weeks) for 8 courses and exemestane 25 mg (orally, continuous daily dose, to be continued until surgery). Patients will start LHRH analogue (Triptorelin 3.75mg 1 fl i.m. every 28 days) concomitantly to anthracycline-based chemotherapy, to be continued until surgery.

Conditions
Breast Cancer
Being tested
Epirubicin, Cyclophosphamide, Triptorelin, Exemestane, Nivolumab
Medical subject headings
Breast Neoplasms

What participants receive

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

  • EpirubicinDrug

    Epirubicin 90 mg/mq i.v. every 3 weeks for three cycles

  • CyclophosphamideDrug

    Cyclophosphamid 600 mg/mq i.v. every 3 weeks for three cycles

  • TriptorelinDrug

    Triptorelin 3.75 mg i.m. every 4 weeks until surgery

  • ExemestaneDrug

    Exemestane 25 mg oral continuous daily dose until surgery

  • NivolumabDrug

    Also called BMS-936558

    Nivolumab 240 mg flat dose i.v. every two weeks for 8 cycles

Study groups in NCT04659551
Study groupRoleWhat they receive
Arm 1ExperimentalEpirubicin 90 mg/mq + Cyclophosphamide 600 mg/mq i.v. every 3 weeks for 3 courses, followed by Nivolumab (240 mg flat dose i.v. each 2 weeks) for 8 courses plus exemestane 25 mg (orally, continuous daily dose, to be continued until surgery). LHRH analogue (Triptorelin 3.75mg 1 fl i.m. every 28 days) started concomitantly to anthracycline based chemotherapy, to be continued until surgery.
Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Triptorelin; Drug: Exemestane; Drug: Nivolumab

What is being measured

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

  1. pathological complete response (pCR)

    ypT0ypN0

    Measured: up to 7 months from enrolment

Secondary outcomes (5)

  1. clinical objective response

    cOR

    Measured: up to 6 months from enrolment

  2. molecular response

    Ki67

    Measured: up to 7 months from enrolment

  3. Breast conserving surgery

    Surgery type

    Measured: up to 7 months from enrolment

  4. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Adverse Events

    Measured: up to 100 days from last nivolumab dose

  5. Correlative biomarkers

    correlation between different biomarkers expression at baseline and pathological response

    Measured: Tumor samples will be collected at baseline, at 14 days after completion of anthracycline-based chemotherapy (about 7 weeks after first dose of Epirubicin), at surgery (about 30 weeks after first dose of Epirubicin)

Timeline

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

  1. First posted9 Dec 2020
  2. Study start5 Oct 2017
  3. Primary completion25 May 2020
  4. Study completion25 May 2020

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
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04659551
Sponsor's protocol ID
GIADA Trial
Other IDs
2016-004665-10, 2016
Acronym
GIADA
Status last verified
Dec 2020
First submitted
23 Feb 2018
Last updated
9 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dieci MV, Guarneri V, Tosi A, Bisagni G, Musolino A, Spazzapan S, Moretti G, Vernaci GM, Griguolo G, Giarratano T, Urso L, Schiavi F, Pinato C, Magni G, Lo Mele M, De Salvo GL, Rosato A, Conte P. Neoadjuvant Chemotherapy and Immunotherapy in Luminal B-like Breast Cancer: Results of the Phase II GIADA Trial. Clin Cancer Res. 2022 Jan 15;28(2):308-317. doi: 10.1158/1078-0432.CCR-21-2260. Epub 2021 Oct 19.

    PubMed 34667023

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epirubicin, Cyclophosphamide and Triptorelin in people with Breast Cancer, run by Istituto Oncologico Veneto IRCCS at 5 sites 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 13 inclusion and 22 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 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

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?

pathological complete response (pCR) (time frame: up to 7 months from enrolment). 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 NCT04659551, which also lists 1 linked publication.

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 Dec 2020.

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