Metastatic Breast Cancer
Conditions
Brief summary
The purpose of the study is to test a treatment strategy with currently approved drugs to see if it is practical to administer the available drugs in a new way that researchers hope could be more effective in treating metastatic breast cancer.
Interventions
DRUGTaxotere
75 mg/m2 once every 21 days for 4 cycles
DRUGCytoxan
600 mg/m2 once every 21 days for 4 cycles
DRUGTrastuzumab deruxtecan
5.4 mg/kg once every 21 days for 5 cycles
DRUGSacituzumab govitecan
10 mg/kg on days 1 and 8 cycled every 21 days for 5 cycles
DRUGXeloda
1000 mg/m2 orally twice daily for 14 days cycled every 21 days for 5 cycles
DRUGFulvestrant
500 mg intramuscular (IM) on days 1, 15 and 28 of the first cycle followed by every 28 days for a total of 4 cycles
DRUGRibociclib
600 mg orally daily 21 days on, 7 days off
DRUGAbemaciclib
150 mg by mouth twice daily
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients 18 years or older * Histologically or cytologically confirmed diagnosis of hormone positive HER2 negative metastatic breast cancer per ASCO/CAP criteria (Allison et al, 2020, Wolff et al, 2018), with diagnosis established through either a breast/axillary biopsy or biopsy of a metastatic lesion. * Hormone positive MBC previously treated with endocrine therapy with either an aromatase inhibitor or Tamoxifen (alone or in combination with a CDK4/6 inhibitor). * Elevated breast tumor markers which may include cancer antigen 15-3 (CA 15-3) levels above the institutional upper limit of normal (ULN) range of 0.0-31.0 U/mL, cancer antigen 27-29 (CA 27-29) (range \<38 U/mL) and/or elevated Carcinoembryonic antigen (CEA) above institutional upper limit of normal (range 0.0 - 5.2 ng/mL). * Presence of measurable disease on imaging via RECIST v1.1. * ECOG performance status 0-1. * Participants must have adequate organ and marrow function as defined in the protocol. * A negative pregnancy test for pre-menopausal women of childbearing potential. * Pre-menopausal women of childbearing potential who are sexually active with a male partner must agree to use adequate contraception prior to the study, for the duration of study participation. * Inclusion of minorities: patients of all races and ethnic groups who meet the above inclusion and below
Exclusion criteria
are eligible for this trial. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Ability to understand and the willingness to sign a written informed consent document or have a legally authorized representative sign on the participant's behalf.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Sequential Therapy | Up to 18 months | The proportion of patients able to complete the sequence of therapies by the conclusion of the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | Up to 18 months | The proportion of patients who experience adverse events or serious adverse events. |
| No Evidence of Disease (NED) | Up to 18 months | The proportion of patients who are able to reach NED status by the conclusion of the trial will be calculated. |
Countries
United States
Contacts
Primary ContactLuza Herrera Dominguez
Outcome results
None listed