Malignant Neoplasms of Female Genital OrgansPhase 2NCT03531645
Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma
A Phase 2 study testing Fulvestrant and Abemaciclib in people with Malignant Neoplasms of Female Genital Organs, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if fulvestrant and abemaciclib can help to control low-grade serous ovarian cancer. The safety of this drug combination will also be studied. This is an investigational study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Neoplasms of Female Genital Organs
- What is being tested?
- Fulvestrant and Abemaciclib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2019to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 with clinical or surgical stage III or IV low-grade serous ovarian, primary peritoneal, or fallopian tube carcinomas who in the judgement of the treating physician are unlikely to achieve optimal surgical cytoreduction and have been recommended to receive neoadjuvant therapy.
- Histological diagnosis must be based on surgical or core biopsy not just fine needle aspiration. Biopsies performed at other institutions must undergo pathology review and confirmation at MD Anderson Cancer Center.
- Tissue from an archival tissue sample or fresh tissue obtained from a core or excisional biopsy of a tumor lesion.
- Willingness to provide pre- and post-treatment tissue for translational studies. Pre-treatment fresh frozen tissue must be available for research purposes. This tissue can be collected from preoperative laparoscopy, other diagnostic biopsy, or a research-specific biopsy.
- Signed informed consent on protocol LAB02-188.
- Tissue from an archival tissue sample or fresh tissue obtained from a core or excisional biopsy of a tumor lesion.
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- Patients whose clinical biopsies are found to be insufficient for the planned translational studies must be willing to undergo a research biopsy.
- Patients must have measurable disease by RECIST v1.1. a. Measurable disease is defined at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each target lesion must be >20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >10 mm when measured by spiral CT.
- Women 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
- Abnormal organ function is permitted. However, patients must have: a. absolute neutrophil count >/= 1500/mL b. platelets >/= 100,000/mL c. hemoglobin >/= 9 g/dL d. estimated creatinine clearance >/= 60 ml/min as calculated using the method standard for the institution e. total serum bilirubin </= 1.5 X ULN f. aspartate aminotransferase (AST/SGOT) and/or alanine aminotransferase (ALT/SGPT) </= 3 X ULN (</= 5 X ULN in patients with bone or liver metastases)
- Resolution of all acute toxic effects of prior therapy or surgical procedures to National Cancer Institute (NCI) CTCAE 4.03 Grade </= 1
- Women of child-bearing potential (intact uterus) MUST have a negative serum or urine human chorionic gonadotropin (HCG) test within 72 hours prior to receiving the first dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female patients of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (Reference Section 7.7). Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Pre/perimenopausal women must be amenable to be treated with goserelin. All patients will be rendered post-menopausal secondary to concomitant administration of goserelin.
- Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures.
Who cannot join
- Patients who are pregnant or breastfeeding.
- The patient has serious preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
- Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers (for examples, see the Prohibited Concomitant Medications section), and drugs that are known to prolong the QT interval (see Prohibited Concomitant Medications in section 7.6.2).
- Diagnosis of another malignancy within 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- Previous chemotherapy or hormonal therapy for treatment of ovarian cancer.
- Known Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) infection.
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- Inability or unwillingness to swallow pills.
- Active infection requiring intravenous (IV) antibiotics or other uncontrolled intercurrent illness requiring hospitalization.
- Inability to comply with the study and follow-up procedures.
- History of any of the following: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), sudden cardiac arrest.
- Prior hematopoietic stem cell or bone marrow transplantation.
- Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant or goserelin (if applicable).
- Known or possible hypersensitivity to fulvestrant, or abemaciclib or any of their excipients.
- Pre/perimenopausal women with a known hypersensitivity to gnRH (gonadotropin-releasing hormone) agonists.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Pilot Phase II Study of Neoadjuvant Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma
The goal of this clinical research study is to learn if fulvestrant and abemaciclib can help to control low-grade serous ovarian cancer. The safety of this drug combination will also be studied.
This is an investigational study. Fulvestrant and abemaciclib are both FDA approved and commercially available for the treatment of several types of cancer. Their use in patients with low-grade serous ovarian cancer is investigational. The study doctor can explain how the study drugs are designed to work.
Up to 15 participants will be enrolled in this study. All will take part at MD Anderson.
Read the detailed description
Study Drug Administration
Every study cycle will be 28 days. You will receive treatment in 2 periods: Neoadjuvant Treatment (before surgery) and Adjuvant Treatment (after surgery).
If you are premenopausal or perimenopausal, you will receive goserelin as an injection under the skin every 12 weeks. The study doctor will tell you if you will have these injections.
Neoadjuvant Treatment (Cycles 1-4) There are 4 cycles in the neoadjuvant treatment period. On Days 1 and 15 of Cycle 1 and Day 1 of Cycles 2-4, you will receive fulvestrant as an injection in your buttocks. On Days 1- 28 of each cycle, you will take abemaciclib tablets 2 times every day by mouth at about the same time each day, preferably with food.
Abemaciclib should be swallowed whole; not chewed. If a tablet is broken, cracked, or otherwise not whole, do not take it.
Surgery After 4 cycles of neoadjuvant treatment, you will have your scheduled surgery as part of your standard care. You will sign a separate consent for this surgery describing the procedure and its risks in more detail.
Adjuvant Treatment (Cycles 5 and beyond) After you have recovered from surgery (about 3-6 weeks later), you will begin receiving fulvestrant and abemaciclib. On Day 1 of each cycle, you will receive fulvestrant as an injection in your buttocks. On Days 1- 28 of each cycle, you will take abemaciclib tablets 2 times every day by mouth.
You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.
Length of Study You will receive the study drug(s) for as long as the study doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation in this study will be over after the 30-day follow-up phone call (described below).
Study Visits
On Day 1 of each cycle:
You will have a physical exam. If the study doctor thinks it is needed, you will also have a pelvic exam.
Blood (about 4 tablespoons) will be drawn for routine, tumor marker, and biomarker tests.
Urine will be collected for routine tests. If you can become pregnant, part of this blood sample will be used for a pregnancy test.
On Day 15 of Cycle 1, you will have a physical exam.
On Day 1 of odd-numbered cycles after Cycle 1 (Cycles 3, 5, 7, and so on), you will have an MRI or CT scan.
At your visit before the surgery, you will have a CT scan or MRI to check the status of the disease.
During surgery, some of the tissue removed will be used to compare to tissue collected from you before you received chemotherapy so researchers can learn if the study drugs had any affect on the disease. This sample will be stored at MD Anderson for an unlimited amount of time for testing related to this study.
End-of-Treatment Visit
After the last dose of study drug(s):
You will have a physical exam. Blood (about 1-2 tablespoons) will be drawn for routine, tumor marker, and biomarker tests.
You will have an MRI or CT scan to check the status of the disease.
Follow-Up About 30 days after the last dose of study drugs, the study staff will call you and ask how you are doing. This call should last about 5 minutes.
- Being tested
- Fulvestrant, Abemaciclib
- Keywords
- Malignant neoplasms of female genital organs, Advanced low grade serous ovarian, primary peritoneal, or fallopian tube carcinomas, Fulvestrant, Faslodex, Abemaciclib, PD-0332991, Ibrance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
Also called Faslodex
Neoadjuvant Treatment (Cycles 1-4): Fulvestrant 500 mg injection in buttocks on Days 1 and 15 of Cycle 1 and Day 1 of Cycles 2-4.
Adjuvant Treatment (Cycles 5 and beyond): Fulvestrant 500 mg injection in buttocks on Day 1 of each cycle.
Study cycle is 28 days.
AbemaciclibDrug
Neoadjuvant Treatment (Cycles 1-4): Abemaciclib 150 mg by mouth On Days 1-28 of each cycle.
Adjuvant Treatment (Cycles 5 and beyond): On Days 1-28 of each cycle, you will take Abemaciclib 150 mg by mouth on Days 1-28 of each cycle.
Study cycle is 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Fulvestrant + Abemaciclib | Experimental | Not described Receives: Drug: Fulvestrant; Drug: Abemaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Rate (CBR)
Clinical benefit rate determined by partial response (PR), complete response (CR), and stable disease (SD) associated with 4 cycles of neoadjuvant abemaciclib plus fulvestrant in patients with Low Grade Serous Carcinoma (LGSC). CBR assessed using RECIST 1.1.
Measured: 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start13 Aug 2019
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasms of Female Genital OrgansStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Amir A. Jazaeri, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531645
- Sponsor's protocol ID
- 2017-0405
- Other IDs
- NCI-2018-00941
- Status last verified
- Sep 2026
- First submitted
- 9 May 2018
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We are pending discussions with Eli Lilly and AstraZeneca regarding the level and quantity of data that may be shared. Discussions will also include potential modifications of the contract to allow for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase II Study of Neoadjuvant Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma
- ClinicalTrials.gov ID
- NCT03531645
- Acronym / sponsor ID
- 2017-0405
- Keywords
- Malignant neoplasms of female genital organs, Advanced low grade serous ovarian, primary peritoneal, or fallopian tube carcinomas, Fulvestrant, Faslodex, Abemaciclib, PD-0332991, Ibrance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- AstraZeneca, Eli Lilly and Company
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if fulvestrant and abemaciclib can help to control low-grade serous ovarian cancer. The safety of this drug combination will also be studied.
This is an investigational study. Fulvestrant and abemaciclib are both FDA approved and commercially available for the treatment of several types of cancer. Their use in patients with low-grade serous ovarian cancer is investigational. The study doctor can explain how the study drugs are designed to work.
Up to 15 participants will be enrolled in this study. All will take part at MD Anderson.
Detailed description
Study Drug Administration
Every study cycle will be 28 days. You will receive treatment in 2 periods: Neoadjuvant Treatment (before surgery) and Adjuvant Treatment (after surgery).
If you are premenopausal or perimenopausal, you will receive goserelin as an injection under the skin every 12 weeks. The study doctor will tell you if you will have these injections.
Neoadjuvant Treatment (Cycles 1-4) There are 4 cycles in the neoadjuvant treatment period. On Days 1 and 15 of Cycle 1 and Day 1 of Cycles 2-4, you will receive fulvestrant as an injection in your buttocks. On Days 1- 28 of each cycle, you will take abemaciclib tablets 2 times every day by mouth at about the same time each day, preferably with food.
Abemaciclib should be swallowed whole; not chewed. If a tablet is broken, cracked, or otherwise not whole, do not take it.
Surgery After 4 cycles of neoadjuvant treatment, you will have your scheduled surgery as part of your standard care. You will sign a separate consent for this surgery describing the procedure and its risks in more detail.
Adjuvant Treatment (Cycles 5 and beyond) After you have recovered from surgery (about 3-6 weeks later), you will begin receiving fulvestrant and abemaciclib. On Day 1 of each cycle, you will receive fulvestrant as an injection in your buttocks. On Days 1- 28 of each cycle, you will take abemaciclib tablets 2 times every day by mouth.
You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.
Length of Study You will receive the study drug(s) for as long as the study doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation in this study will be over after the 30-day follow-up phone call (described below).
Study Visits
On Day 1 of each cycle:
You will have a physical exam. If the study doctor thinks it is needed, you will also have a pelvic exam.
Blood (about 4 tablespoons) will be drawn for routine, tumor marker, and biomarker tests.
Urine will be collected for routine tests. If you can become pregnant, part of this blood sample will be used for a pregnancy test.
On Day 15 of Cycle 1, you will have a physical exam.
On Day 1 of odd-numbered cycles after Cycle 1 (Cycles 3, 5, 7, and so on), you will have an MRI or CT scan.
At your visit before the surgery, you will have a CT scan or MRI to check the status of the disease.
During surgery, some of the tissue removed will be used to compare to tissue collected from you before you received chemotherapy so researchers can learn if the study drugs had any affect on the disease. This sample will be stored at MD Anderson for an unlimited amount of time for testing related to this study.
End-of-Treatment Visit
After the last dose of study drug(s):
You will have a physical exam. Blood (about 1-2 tablespoons) will be drawn for routine, tumor marker, and biomarker tests.
You will have an MRI or CT scan to check the status of the disease.
Follow-Up About 30 days after the last dose of study drugs, the study staff will call you and ask how you are doing. This call should last about 5 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fulvestrant + Abemaciclib | Experimental | Drug: Fulvestrant, Drug: Abemaciclib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with clinical or surgical stage III or IV low-grade serous ovarian, primary peritoneal, or fallopian tube carcinomas who in the judgement of the treating physician are unlikely to achieve optimal surgical cytoreduction and have been recommended to receive neoadjuvant therapy.
- Histological diagnosis must be based on surgical or core biopsy not just fine needle aspiration. Biopsies performed at other institutions must undergo pathology review and confirmation at MD Anderson Cancer Center.
- Tissue from an archival tissue sample or fresh tissue obtained from a core or excisional biopsy of a tumor lesion.
- Willingness to provide pre- and post-treatment tissue for translational studies. Pre-treatment fresh frozen tissue must be available for research purposes. This tissue can be collected from preoperative laparoscopy, other diagnostic biopsy, or a research-specific biopsy.
- Signed informed consent on protocol LAB02-188.
Key exclusion criteria (14 listed)
- Patients who are pregnant or breastfeeding.
- The patient has serious preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
- Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers (for examples, see the Prohibited Concomitant Medications section), and drugs that are known to prolong the QT interval (see Prohibited Concomitant Medications in section 7.6.2).
- Diagnosis of another malignancy within 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- Previous chemotherapy or hormonal therapy for treatment of ovarian cancer.
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: FaslodexNeoadjuvant Treatment (Cycles 1-4): Fulvestrant 500 mg injection in buttocks on Days 1 and 15 of Cycle 1 and Day 1 of Cycles 2-4. Adjuvant Treatment (Cycles 5 and beyond): Fulvestrant 500 mg injection in buttocks on Day 1 of each cycle. Study cycle is 28 days. | Drug | Fulvestrant + Abemaciclib |
| AbemaciclibNeoadjuvant Treatment (Cycles 1-4): Abemaciclib 150 mg by mouth On Days 1-28 of each cycle. Adjuvant Treatment (Cycles 5 and beyond): On Days 1-28 of each cycle, you will take Abemaciclib 150 mg by mouth on Days 1-28 of each cycle. Study cycle is 28 days. | Drug | Fulvestrant + Abemaciclib |
Primary outcome
Clinical Benefit Rate (CBR)
Time frame: 112 days
Clinical benefit rate determined by partial response (PR), complete response (CR), and stable disease (SD) associated with 4 cycles of neoadjuvant abemaciclib plus fulvestrant in patients with Low Grade Serous Carcinoma (LGSC). CBR assessed using RECIST 1.1.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. We are pending discussions with Eli Lilly and AstraZeneca regarding the level and quantity of data that may be shared. Discussions will also include potential modifications of the contract to allow for data sharing.
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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.
Amir A. Jazaeri, MD principal investigator
M.D. Anderson Cancer Center
1 site 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 and Abemaciclib in people with Malignant Neoplasms of Female Genital Organs, run by M.D. Anderson Cancer Center at 1 site 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 16 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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical Benefit Rate (CBR) (time frame: 112 days). 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 14 Sep 2026.