Metastatic Breast CancerPhase 2NCT06409390
Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer
A Phase 2 study testing Taxotere, Cytoxan and Trastuzumab deruxtecan in people with Metastatic Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Taxotere, Cytoxan and Trastuzumab deruxtecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to Apr 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
- 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.
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- 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.
Who cannot join
- Have previously received Fulvestrant for treatment of their breast cancer.
- History of allergic reactions attributed to the study drugs.
- Documented brain metastasis or active or newly diagnosed CNS metastases, including meningeal carcinomatosis, because systemic treatment would need to be paused for these patients.
- Treatment with any investigational compound within 30 days prior to the first dose of study drugs or during this study.
- Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Uncontrolled intercurrent illness including-but not limited to-ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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- Patients with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis.
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
- Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg]), or hepatitis C (HCV). Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Participants with positive HCV antibody are eligible if polymerase chain reaction is negative for HCV RNA.
- Concurrent or prior use of immunosuppressive medication within 14 days before the first dose of study drugs, with the following exceptions: premedication with dexamethasone, intranasal, inhaled, topical or local steroid injections, systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or its equivalent; steroids as premedication for hypersensitivity reactions (e.g., premedication for iodinated contrast allergy before CT scan).
- Inability to comply with protocol requirements.
- Pregnant and/or breastfeeding women are excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Aixa Soyano, MD
Dana Ataya, MD
About this study
Official title: A Pilot Study of Sequential ("First Strike, Second Strike") Therapies, Modeled on Evolutionary Dynamics of Anthropocene Extinctions, for Hormone Positive Metastatic Breast Cancer
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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Taxotere, Cytoxan, Trastuzumab deruxtecan, Sacituzumab govitecan, Xeloda
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaxotereDrug
Also called Docetaxel
75 mg/m2 once every 21 days for 4 cycles
CytoxanDrug
Also called Cyclophosphamide
600 mg/m2 once every 21 days for 4 cycles
Trastuzumab deruxtecanDrug
Also called Enhertu
5.4 mg/kg once every 21 days for 5 cycles
Sacituzumab govitecanDrug
Also called Trodelvy
10 mg/kg on days 1 and 8 cycled every 21 days for 5 cycles
XelodaDrug
Also called Capecitabine
1000 mg/m2 orally twice daily for 14 days cycled every 21 days for 5 cycles
FulvestrantDrug
Also called Faslodex
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
RibociclibDrug
Also called Kisqali
600 mg orally daily 21 days on, 7 days off
AbemaciclibDrug
Also called Verzenio
150 mg by mouth twice daily
| Study group | Role | What they receive |
|---|---|---|
| Sequential therapy | Experimental | In this study sequential therapies will be administered.
Strike 1: Cytoxan/Taxotere/GM-CSF Strike 2: Sacituzumab govitecan or trastuzumab deruxtecan Strike 3: Capecitabine Strike 4: Fulvestrant + CDK 4/6 inhibitor (ribociclib or abemaciclib) Receives: Drug: Taxotere; Drug: Cytoxan; Drug: Trastuzumab deruxtecan; Drug: Sacituzumab govitecan; Drug: Xeloda; Drug: Fulvestrant; Drug: Ribociclib; Drug: Abemaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Sequential Therapy
The proportion of patients able to complete the sequence of therapies by the conclusion of the trial.
Measured: Up to 18 months
Secondary outcomes (2)
Safety and Tolerability
The proportion of patients who experience adverse events or serious adverse events.
Measured: Up to 18 months
No Evidence of Disease (NED)
The proportion of patients who are able to reach NED status by the conclusion of the trial will be calculated.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start14 Aug 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aixa Soyano, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409390
- Sponsor's protocol ID
- MCC-22617
- Status last verified
- Dec 2025
- First submitted
- 7 May 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Sequential ("First Strike, Second Strike") Therapies, Modeled on Evolutionary Dynamics of Anthropocene Extinctions, for Hormone Positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06409390
- Acronym / sponsor ID
- MCC-22617
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 10 May 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential therapy | Experimental | Drug: Taxotere, Drug: Cytoxan, Drug: Trastuzumab deruxtecan, Drug: Sacituzumab govitecan, Drug: Xeloda, Drug: Fulvestrant, Drug: Ribociclib, Drug: AbemaciclibIn this study sequential therapies will be administered. Strike 1: Cytoxan/Taxotere/GM-CSF Strike 2: Sacituzumab govitecan or trastuzumab deruxtecan Strike 3: Capecitabine Strike 4: Fulvestrant + CDK 4/6 inhibitor (ribociclib or abemaciclib) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (12 listed)
- Have previously received Fulvestrant for treatment of their breast cancer.
- History of allergic reactions attributed to the study drugs.
- Documented brain metastasis or active or newly diagnosed CNS metastases, including meningeal carcinomatosis, because systemic treatment would need to be paused for these patients.
- Treatment with any investigational compound within 30 days prior to the first dose of study drugs or during this study.
- Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
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 |
|---|---|---|
| TaxotereAlso: Docetaxel75 mg/m2 once every 21 days for 4 cycles | Drug | Sequential therapy |
| CytoxanAlso: Cyclophosphamide600 mg/m2 once every 21 days for 4 cycles | Drug | Sequential therapy |
| Trastuzumab deruxtecanAlso: Enhertu5.4 mg/kg once every 21 days for 5 cycles | Drug | Sequential therapy |
| Sacituzumab govitecanAlso: Trodelvy10 mg/kg on days 1 and 8 cycled every 21 days for 5 cycles | Drug | Sequential therapy |
| XelodaAlso: Capecitabine1000 mg/m2 orally twice daily for 14 days cycled every 21 days for 5 cycles | Drug | Sequential therapy |
| FulvestrantAlso: Faslodex500 mg intramuscular (IM) on days 1, 15 and 28 of the first cycle followed by every 28 days for a total of 4 cycles | Drug | Sequential therapy |
| RibociclibAlso: Kisqali600 mg orally daily 21 days on, 7 days off | Drug | Sequential therapy |
| AbemaciclibAlso: Verzenio150 mg by mouth twice daily | Drug | Sequential therapy |
Primary outcome
Feasibility of Sequential Therapy
Time frame: Up to 18 months
The proportion of patients able to complete the sequence of therapies by the conclusion of the trial.
2 secondary outcomes
Safety and Tolerability
Time frame: Up to 18 months
No Evidence of Disease (NED)
Time frame: Up to 18 months
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 4 Dec 2025.
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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.
Aixa Soyano, MD principal investigator
Moffitt 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 Taxotere, Cytoxan and Trastuzumab deruxtecan in people with Metastatic Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute 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 12 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. 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?
Contact Luza Herrera Dominguez (813-745-5332, Luza.Herrera@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Sequential Therapy (time frame: Up to 18 months). 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 4 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.