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Metastatic ER+ Breast CancerPhase 1NCT03201913

Study of TTC-352 in Patients With Metastatic Breast Cancer Progressing on Endocrine Therapy

A Phase 1 study testing TTC-352 in people with Metastatic ER+ Breast Cancer, run by TTC Oncology, LLC at 4 sites in United States.

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

Phase1 study of TTC 352 for treatment of metastatic ER+ breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic ER+ Breast Cancer
What is being tested?
TTC-352
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
4 sitesUnited States
Study dates
11 Dec 2017to 30 Apr 2020
Phase
Phase 1
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

  • be ≥18 years of age;
  • have a diagnosis of metastatic ER+ breast cancer in patients who received and progressed on at least two lines of endocrine therapy, with one that included a CDK4/CDK6 inhibitor (e.g., palbociclib or ribociclib);
  • have metastatic disease evaluable on imaging studies;
  • have a histologically confirmed diagnosis of ER+ breast cancer;
  • have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (Appendix II);
  • have adequate hepatic function, defined as having a serum total bilirubin concentration ≤1.5mg/d, or ≤2 x the upper limit of normal (ULN) if associated with hepatobiliary metastases or Gilbert syndrome, and having serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) concentrations ≤2.5 × ULN, or ≤5 x ULN for patients with known hepatic metastases;
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  • have adequate renal function, defined as having a serum creatinine ≤1.5 × ULN and a creatinine clearance ≥40mL/min (estimated using the Cockcroft-Gault formula);
  • have adequate hematologic function, defined as having a hemoglobin ≥8g/dL, an absolute neutrophil count (ANC) ≥1.0 × 109/L, and platelet count ≥75.0 x 109/L;
  • be willing and able to comply with study visits and procedures;
  • have read, understood and signed the informed consent form (ICF) approved by the Institutional Review Board (IRB);
  • if a woman of childbearing potential (WOCP), not be pregnant (confirmed by a negative serum pregnancy test within 14 days of study entry and re-confirmed by a urine pregnancy test on the morning of Study Day 1, prior to the start of study treatment) and/or not be breast-feeding; [Note: Women who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are not considered to be a WOCP.]
  • If a WOCP, agree to use during the study and for at least one month after the last dose of study drug a medically acceptable method of birth control [such as an oral, implantable, injectable, or transdermal hormonal contraceptive, an intrauterine device (IUD), a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence.];
  • if male (and whether or not surgically or medically sterile), agree to use during the study and for at least one month after the last dose of study drug a double barrier method of birth control (in addition to any other birth control method practiced by his partner) while engaging in sexual intercourse with a partner who is pregnant, possibly pregnant or able to become pregnant.

Who cannot join

  • have received chemotherapy, hormonal therapy, biologic therapy, immunotherapy or radiation therapy within 14 days prior to the planned start of study treatment.
  • have inadequate recovery* from adverse events resulting from previously-administered anti-cancer therapies; [*Note: Unless more specifically defined in Inclusion Criteria 6, 7 and 8 above, adequate recovery is defined as improvement to ≤ Grade 2 for any other hematologic toxicity and for peripheral neuropathy, and improvement to ≤ Grade 1 for any other non-hematologic toxicity.]
  • have a history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism or retinal vein thrombosis, unless currently on anticoagulant therapy;
  • have impending visceral crisis that requires chemotherapy;
  • have known uncontrolled or symptomatic CNS metastases;
  • have any clinically significant infection, defined as any acute viral, bacterial, or fungal infection that requires systemic treatment or have received any anti-infective treatment within 7 days prior to the screening visit;
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  • have any other severe, uncontrolled medical condition, including unstable congestive heart failure (Stage III-IV of the New York Heart Association Functional Classification (Appendix III))
  • have a known or suspected allergy to the study drug or any study drug component;
  • have any other medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, that may interfere with the interpretation of study results or that otherwise would, in the opinion of the Investigator, make study participation inappropriate;
  • have any non-healing wound, fracture, or ulcer within 28 days prior to the planned start of study treatment;
  • have received any other investigational drug within 28 days (or 5 half-lives, if longer) prior to the start of study screening.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Wisconsin, Carbone Cancer Center

    Madison, Wisconsin, 53792

  • HealthPartners Institute, Regions Cancer Care Center

    Saint Paul, Minnesota, 55101

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

  • Sanford Health

    Sioux Falls, South Dakota, 57104

Other trials in United States

About this study

Official title: Phase 1 Study of TTC-352 in Patients With Metastatic Breast Cancer Progressing on Endocrine Therapy

Phase1 study of TTC 352 for treatment of metastatic ER+ breast cancer.

Read the detailed description

This is open-label, accelerated dose escalation study of TTC 352, a selective human ER partial agonist for treatment of metastatic ER+ breast cancer in patients who received and progressed on at least two lines of endocrine therapy with one that included a CDK4/CDK6 inhibitor.

The primary objective of this study is to determine the maximum tolerated dose (MTD) of TTC-352 for the treatment of metastatic ER+ breast cancer progressing after endocrine therapy.

The maximum tolerated dose (MTD) of TTC-352 will be determined using initial single-patient cohort escalations until grade 2 toxicity, then expansion to a modified-Fibonacci dose-escalation 3+3 design. Patients enrolled at each dose escalation step must complete the first 28-day cycle of treatment without a dose-limiting toxicity (DLT), or be withdrawn because of a DLT, before additional patients may be enrolled for the next dose escalation step. The MTD dose level cohort will be expanded to a total of 9 patients, to further evaluate safety. In each cohort pharmacokinetics of TTC-352 will be evaluated.

Being tested
TTC-352

What participants receive

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

  • TTC-352Drug

    Also called Selective Human Estrogen Receptor Partial Agonist

    Phase 1 study to determine the maximum tolerated dose (MTD) of TTC-352.

Study groups in NCT03201913
Study groupRoleWhat they receive
Accelerated dose escalation studyExperimentalDose escalation of TTC-352 administered as an oral capsule, twice a day for 28 days (one cycle). Patients will receive sequential 28-day cycles of treatment until disease progression, unacceptable toxicity, patient refusal to continue treatment, any other reason to discontinue treatment (e.g., further participation is not in the patient's best interest) or study completion/termination.
Receives: Drug: TTC-352

What is being measured

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

  1. MTD

    The primary objective of this study is to determine the maximum tolerated dose (MTD) of TTC-352 for the treatment of metastatic ER+ breast cancer progressing after endocrine therapy

    Measured: 24 months

Secondary outcomes (6)

  1. Best response to treatment

    Determine patient best response to treatment (complete response, partial response, stable disease or disease progression) after at least two 28-day cycles of treatment with TTC 352.

    Measured: 24 months

  2. PFS

    Determine durations of progression-free survival after at least two 28-day cycles of treatment with TTC 352

    Measured: 24 months

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Treatment-related adverse events as assessed by CTCAE v4.0 will be collected in presented in tabular form at the end of study.

    Measured: 24 months

  4. Maximum Plasma Concentration (Cmax)

    Blood samples will be collected at the following Cycle 1 time points:

    Day 1: prior to dosing and at Hours 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 after dosing (just before dosing on Day 2).

    Day 28: prior to dosing and at Hours 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 28 after dosing.

    TTC-352 blood levels will be measured at above time points and Cmax will be calculated.

    Measured: 24 months

  5. Half life

    Blood samples will be collected at the following Cycle 1 time points:

    Day 1: prior to dosing and at Hours 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 after dosing (just before dosing on Day 2).

    Day 28: prior to dosing and at Hours 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 28 after dosing.

    TTC-352 blood levels will be measured at above time points and half life of TTC-352 will be calculated.

    Measured: 24 months

  6. Area Under the Curve (AUC)

    Blood samples will be collected at the following Cycle 1 time points:

    Day 1: prior to dosing and at Hours 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 after dosing (just before dosing on Day 2).

    Day 28: prior to dosing and at Hours 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 28 after dosing.

    TTC-352 blood levels will be measured at above time points and AUC will be calculated.

    Measured: 24 months

Timeline

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

  1. First posted28 Jun 2017
  2. Study start11 Dec 2017
  3. Primary completion31 Dec 2019
  4. Study completion30 Apr 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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label, accelerated dose escalation study.
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03201913
Sponsor's protocol ID
TTC-352-101
Status last verified
Aug 2020
First submitted
23 Jun 2017
Last updated
11 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: At present TTC Oncology does not plan to share IPD with other researchers.

Publications

  • Dudek AZ, Liu LC, Fischer JH, Wiley EL, Sachdev JC, Bleeker J, Hurley RW, Tonetti DA, Thatcher GRJ, Venuti RP, O'Regan RM. Phase 1 study of TTC-352 in patients with metastatic breast cancer progressing on endocrine and CDK4/6 inhibitor therapy. Breast Cancer Res Treat. 2020 Oct;183(3):617-627. doi: 10.1007/s10549-020-05787-z. Epub 2020 Jul 22.

    PubMed 32696319

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TTC-352 in people with Metastatic ER+ Breast Cancer, run by TTC Oncology, LLC at 4 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 13 inclusion and 11 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 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

MTD (time frame: 24 months). 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 NCT03201913, 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 11 Aug 2020.

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