Female Breast CarcinomaPhase 2007NCT02540330
A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant
A Phase 2 study testing Fulvestrant in people with Female Breast Carcinoma and Female Ductal Carcinoma In Situ, run by Atossa Therapeutics, Inc. at 3 sites in United States.
Trial summary
This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or DCIS. The first subject of each of five groups will receive fulvestrant intramuscularly. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Breast Carcinoma, Female Ductal Carcinoma In Situ
- What is being tested?
- Fulvestrant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2016to 13 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Female
- 18 years of age or older
- Scheduled to undergo non-nipple sparing mastectomy for Invasive Breast Cancer or DCIS
- Pathological diagnosis of Invasive Ductal Breast Cancer or Ductal Carcinoma in Situ requiring mastectomy or lumpectomy
- Estrogen Receptor-positive pathology
- ECOG performance scale of 0-1
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- Adequate organ function as defined by the following criteria:
- Absolute neutrophil count (ANC) ≥ 1500/μl
- Platelets ≥ 100,000/μl
- Hemoglobin ≥ 9.0 g/dl
- Creatinine ≤ 2 times upper limit of normal
- Bilirubin ≤ 2 times upper limit of normal
- Transaminases (AST/SGOT and ALT/SGPT) ≤ 2.5 times upper limit of normal
- Able to sign informed consent
- Willing to use effective contraception for at least 100 days post study drug administration.
Who cannot join
- Concurrent treatment with another anti-estrogen
- Presence of an active infection requiring systemic therapy
- The following conditions contra-indicating fulvestrant administration:
- Subjects with bleeding diatheses, thrombocytopenia or current anticoagulant use (excluding aspirin and anti-inflammatories)
- Subjects with a known hypersensitivity to fulvestrant or any of its formulation components including castor oil, alcohol, benzyl alcohol, and benzyl benzoate.
- Severe hepatic impairment.
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- Prior surgery on the ipsilateral breast which interrupts communication of the ductal systems with the nipple
- Prior radiation to the breast
- Pregnant or lactating
- Impaired cardiac function or history of cardiac problems of NYHA Class 111 and IV
- Poor nutritional state as indicated by a BMI below 20.
- Presence of serious infection not controlled with systemic therapy
- History of allergies to Lidocaine or Novocain
- Concurrent participation in an experimental drug study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
Columbia University Medical Center
New York, New York, 10032
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: An Open Label, Phase 2 Pharmacokinetic Study of Pre-Surgical Intramuscular and Intraductal Fulvestrant in Women With Invasive Breast Cancer or DCIS Undergoing Mastectomy or Lumpectomy
This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or DCIS. The first subject of each of five groups will receive fulvestrant intramuscularly. The subsequent 5 subjects of each group will receive fulvestrant by intraductal instillation. All subjects will be monitored for systemic and local adverse events during the procedure, and following the procedure until mastectomy or lumpectomy. Subjects that receive fulvestrant will undergo serial blood draws to determine fulvestrant blood concentration levels.
Read the detailed description
This is an open-label, non-randomized pharmacokinetic study of pre-surgical fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified upon admission to the institution for surgical management of breast cancer or DCIS, specifically mastectomy or lumpectomy. There will be 5 groups, each consisting of 6 subjects. The first subject of each group will receive fulvestrant administered intramuscularly and the next 5 subjects will receive fulvestrant intraductally. Subjects where at least 1 suitable duct is identified may undergo nipple aspiration in order to facilitate duct identification and intraductal infusion of a fulvestrant accompanied by imaging (saline+ ultrasound). A maximum of 5 ducts will receive intraductal infusion of fulvestrant. Across all ducts, the total dose will not exceed 500 mg (10 mL). All subjects will be monitored for systemic and local adverse events during the procedure, immediately following the procedure, within 30 minutes, 1 hour, 4 hours and by phone following discharge on Days +1 and +2, +7, and pre-operative. Subsequent to mastectomy or lumpectomy, subjects will be assessed for systemic adverse events until discharge. Subjects that receive fulvestrant will undergo serial blood draws to determine fulvestrant blood concentration levels.
This study was terminated due to revised commercial analyses including a review of the potential to enroll in a timely manner the planned number of patients. This study was not terminated because of safety or efficacy concerns.
- Being tested
- Fulvestrant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
Also called Faslodex
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular Fulvestrant | Active comparator | 500mg fulvestrant administered intramuscularly Receives: Drug: Fulvestrant |
| Intraductal Fulvestrant | Experimental | up to 500mg fulvestrant administered intraductally Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Two Delivery Methods
Number of adverse events per CTCAE v4.0 after treatment with fulvestrant by route of administration
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startMar 2016
- Primary completion13 Aug 2020
- Study completion13 Aug 2020
Why it stopped: Business decision (See Detailed Description)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Female Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atossa Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven C Quay, Study chair, Atossa Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540330
- Sponsor's protocol ID
- ATOS-2015-007
- Acronym
- 007
- Status last verified
- Apr 2024
- First submitted
- 28 Aug 2015
- Last updated
- 3 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase 2 Pharmacokinetic Study of Pre-Surgical Intramuscular and Intraductal Fulvestrant in Women With Invasive Breast Cancer or DCIS Undergoing Mastectomy or Lumpectomy
- ClinicalTrials.gov ID
- NCT02540330
- Acronym / sponsor ID
- 007 / ATOS-2015-007
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision (See Detailed Description)
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Atossa Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- 13 Aug 2020 (actual)
- Study completion
- 13 Aug 2020 (actual)
- First posted
- 3 Sep 2015 (estimated)
- Results
- Posted 5 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or DCIS. The first subject of each of five groups will receive fulvestrant intramuscularly. The subsequent 5 subjects of each group will receive fulvestrant by intraductal instillation. All subjects will be monitored for systemic and local adverse events during the procedure, and following the procedure until mastectomy or lumpectomy. Subjects that receive fulvestrant will undergo serial blood draws to determine fulvestrant blood concentration levels.
Detailed description
This is an open-label, non-randomized pharmacokinetic study of pre-surgical fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified upon admission to the institution for surgical management of breast cancer or DCIS, specifically mastectomy or lumpectomy. There will be 5 groups, each consisting of 6 subjects. The first subject of each group will receive fulvestrant administered intramuscularly and the next 5 subjects will receive fulvestrant intraductally. Subjects where at least 1 suitable duct is identified may undergo nipple aspiration in order to facilitate duct identification and intraductal infusion of a fulvestrant accompanied by imaging (saline+ ultrasound). A maximum of 5 ducts will receive intraductal infusion of fulvestrant. Across all ducts, the total dose will not exceed 500 mg (10 mL). All subjects will be monitored for systemic and local adverse events during the procedure, immediately following the procedure, within 30 minutes, 1 hour, 4 hours and by phone following discharge on Days +1 and +2, +7, and pre-operative. Subsequent to mastectomy or lumpectomy, subjects will be assessed for systemic adverse events until discharge. Subjects that receive fulvestrant will undergo serial blood draws to determine fulvestrant blood concentration levels.
This study was terminated due to revised commercial analyses including a review of the potential to enroll in a timely manner the planned number of patients. This study was not terminated because of safety or efficacy concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramuscular Fulvestrant | Active comparator | Drug: Fulvestrant500mg fulvestrant administered intramuscularly |
| Intraductal Fulvestrant | Experimental | Drug: Fulvestrantup to 500mg fulvestrant administered intraductally |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Female
- 18 years of age or older
- Scheduled to undergo non-nipple sparing mastectomy for Invasive Breast Cancer or DCIS
- Pathological diagnosis of Invasive Ductal Breast Cancer or Ductal Carcinoma in Situ requiring mastectomy or lumpectomy
- Estrogen Receptor-positive pathology
Key exclusion criteria (14 listed)
- Concurrent treatment with another anti-estrogen
- Presence of an active infection requiring systemic therapy
- The following conditions contra-indicating fulvestrant administration:
- Prior surgery on the ipsilateral breast which interrupts communication of the ductal systems with the nipple
- Prior radiation to the breast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FulvestrantAlso: Faslodex | Drug | Intraductal Fulvestrant, Intramuscular Fulvestrant |
Primary outcome
Safety and Tolerability of Two Delivery Methods
Time frame: Up to 4 weeks
Number of adverse events per CTCAE v4.0 after treatment with fulvestrant by route of administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven C Quay study chair
Atossa Therapeutics, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fulvestrant in people with Female Breast Carcinoma and Female Ductal Carcinoma In Situ, run by Atossa Therapeutics, Inc. at 3 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 14 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: stopped early, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 5 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety and Tolerability of Two Delivery Methods (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2024.