A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant (007)
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ClinicalTrials.gov Identifier: NCT02540330 |
Recruitment Status :
Terminated
(Business decision)
First Posted : September 3, 2015
Results First Posted : April 5, 2022
Last Update Posted : April 5, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Female Breast Carcinoma Female Ductal Carcinoma In Situ | Drug: Fulvestrant | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | March 2016 |
Actual Primary Completion Date : | August 13, 2020 |
Actual Study Completion Date : | August 13, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Intramuscular Fulvestrant
500mg fulvestrant administered intramuscularly
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Drug: Fulvestrant
Other Name: Faslodex |
Experimental: Intraductal Fulvestrant
up to 500mg fulvestrant administered intraductally
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Drug: Fulvestrant
Other Name: Faslodex |
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Concurrent treatment with another anti-estrogen
- Presence of an active infection requiring systemic therapy
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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.
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540330
United States, Maryland | |
The Johns Hopkins School of Medicine | |
Baltimore, Maryland, United States, 21205 | |
United States, New York | |
Montefiore Medical Center | |
New York, New York, United States, 10461 |
Study Chair: | Steven C Quay | Atossa Therapeutics, Inc. |
Documents provided by Atossa Therapeutics, Inc.:
Responsible Party: | Atossa Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT02540330 |
Other Study ID Numbers: |
ATOS-2015-007 |
First Posted: | September 3, 2015 Key Record Dates |
Results First Posted: | April 5, 2022 |
Last Update Posted: | April 5, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Breast Neoplasms Carcinoma in Situ Carcinoma, Ductal Carcinoma, Intraductal, Noninfiltrating Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary Breast Carcinoma In Situ Fulvestrant Antineoplastic Agents, Hormonal Antineoplastic Agents Estrogen Receptor Antagonists Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |