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Breast NeoplasmsPhase 2NEOADAPTNCT02689921

NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer

A Phase 2 study testing Exemestane, Letrozole and Anastrozole in people with Breast Neoplasms, run by Midwestern Regional Medical Center at 2 sites in United States.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a prospective, single-arm, phase II study of 32 evaluable patients treated with NEOADjuvant Aromatase inhibitor and Pertuzumab/Trastuzumab (NEOADAPT) without chemotherapy for hormone receptor positive (HR+), [i.e. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Neoplasms
What is being tested?
Exemestane, Letrozole and Anastrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
2 sitesUnited States
Study dates
Apr 2016to Dec 2018
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to provide signed, written informed consent
  • Histologically or cytologically confirmed non-metastatic adenocarcinoma of the breast (stage I-II)
  • Candidate for curative-intent treatment
  • ER+ and/or PR+ and HER2-positive (Fluorescence In Situ Hybridization-positive or 3+ by Immunohistochemistry staining)
  • Life expectancy greater than 5 years
  • Left Ventricular Ejection Fraction > 50% at baseline (within 30 days of day 0)
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  • Eastern Cooperative Oncology Group performance status ≤2
  • Absolute Neutrophil Count >1000/µL
  • Platelets ≥50,000/µL
  • Hemoglobin >8.0 g/dL,
  • Creatinine ≤3.0 x upper limit of normal (ULN)
  • Bilirubin ≤3.0 x ULN
  • Aspartate aminotransferase or Alanine aminotransferase <5.0 x ULN
  • Negative serum pregnancy test for women <12 months after the onset of menopause unless surgically sterilized
  • Agreement by women of childbearing potential and male participants with partners of childbearing potential to use a "highly effective", non-hormonal form of contraception or two "effective" forms of non-hormonal contraception by the patient and/or partner.

Who cannot join

  • Active infection
  • Presence of known metastases (stage IV disease)
  • Pregnant or lactating women
  • Prior chemotherapy or radiation therapy for the primary breast cancer
  • Concomitant malignancies or previous malignancies within the last 5 years except adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  • History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
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  • Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary or metabolic disease including diabetes, wound healing disorders, ulcers or bone fractures)
  • Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipated need for major surgery during the course of study treatment
  • Current known infection with Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV) or Hepatitis C Virus (HCV)
  • Receipt of intravenous antibiotics for infection within 14 days prior to receiving study treatment
  • Current chronic daily treatment with corticosteroids (dose >10 mg/day methylprednisolone equivalent) except inhaled steroids
  • Known hypersensitivity to any of the study drugs
  • Assessment by the investigator to be unable or unwilling to comply with the requirements of the protocol

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Southeastern Regional Medical Center

    Newnan, Georgia, 30265

  • Cancer Treatment Centers of America at Midwestern Regional Medical Center

    Zion, Illinois, 60099

Other trials in United States

About this study

Official title: A Phase II Study of NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab (NEOADAPT)

This is a prospective, single-arm, phase II study of 32 evaluable patients treated with NEOADjuvant Aromatase inhibitor and Pertuzumab/Trastuzumab (NEOADAPT) without chemotherapy for hormone receptor positive (HR+), [i.e. Estrogen Receptor positive (ER+) and/or Progesterone Receptor positive (PR+)] HER2+ localized, non-metastatic stage I - IIb breast cancer.

Being tested
Exemestane, Letrozole, Anastrozole, Leuprolide Acetate, Pertuzumab
Medical subject headings
Breast Neoplasms

What participants receive

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

  • ExemestaneDrug

    Also called Aromasin

    Aromatase inhibitor

  • LetrozoleDrug

    Also called Femara

    Aromatase inhibitor

  • AnastrozoleDrug

    Also called Arimidex

    Aromatase inhibitor

  • Leuprolide AcetateDrug

    Also called Lupron, Lupron Depot

    Luteinizing Hormone-Releasing Hormone agonist

  • PertuzumabDrug

    Also called Perjeta

    Monoclonal antibody (HER2/neu receptor antagonist)

  • TrastuzumabDrug

    Also called Herceptin

    Monoclonal antibody (HER2/neu receptor antagonist)

Study groups in NCT02689921
Study groupRoleWhat they receive
Neoadjuvant Biological TherapyExperimentalSubjects will receive an aromatase inhibitor for the duration of the study [exemestane (tablet, oral, 25 mg/day), letrozole (tablet, oral, 2.5 mg/day) or anastrozole (tablet, oral, 1 mg/day)]. Premenopausal subjects will receive leuprolide acetate (11.25 mg, intramuscular injection, 3-month intervals). Pertuzumab will be given by intravenous infusion in 3-week cycles until disease progression (Cycle 1 Day 0: 840 mg, infused over 60-90 minutes; subsequent cycles: 420 mg, infused over 30-60 minutes). Trastuzumab will be given by intravenous infusion in 3-week cycles until disease progression (Cycle 1 Day 0: 8 mg/kg, infused over 60-90 minutes; subsequent cycles: 6 mg/kg, infused over 30-60 minutes)
Receives: Drug: Exemestane; Drug: Letrozole; Drug: Anastrozole; Drug: Leuprolide Acetate; Drug: Pertuzumab; Drug: Trastuzumab

What is being measured

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

  1. Evidence of Pathological Response

    The presence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy. Pathological complete response (pCR) is defined as the absence of residual invasive cancer.

    Measured: One year

Secondary outcomes (4)

  1. Duration of Treatment

    Median number of days between Day 0 (first treatment of trastuzumab and pertuzumab) and three weeks after the last dose of neoadjuvant trastuzumab and pertuzumab on treatment protocol.

    Measured: One year

  2. Evidence of Radiographic Response

    Change in dimensions (millimeters) of target lesions (along long axis) and non-target lesions (along long axis for non-lymphatic lesions and short axis for lymph nodes) as observed by Magnetic Resonance Imaging and quantified by modified RECIST 1.1 criteria.

    Measured: Assessed every 12 weeks up to one year

  3. Measurement of Left Ventricular Ejection Fraction (LVEF)

    Determination of cardiac function as measured by echocardiogram or multi-gated acquisition scan (MUGA).

    Measured: Assessed every 12 weeks up to one year

  4. Mammaprint Genomic Analysis

    Mammaprint will estimate the risk level of the subject's tumor.

    Measured: One year or up to 3 months after definitive surgery

Timeline

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

  1. First posted24 Feb 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (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
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02689921
Sponsor's protocol ID
MZ2016006
Other IDs
ML30001
Acronym
NEOADAPT
Status last verified
Sep 2018
First submitted
4 Feb 2016
Last updated
28 Sep 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Exemestane, Letrozole and Anastrozole in people with Breast Neoplasms, run by Midwestern Regional Medical Center at 2 sites in United States.

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 15 inclusion and 13 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 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Evidence of Pathological Response (time frame: One year). 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 NCT02689921.

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 28 Sep 2018.

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