Estrogen-receptor-positive Breast Cancer study: Capecitabine vs Elacestrant
Official title PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)
ClinicalTrials.gov ID: NCT07222215
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, taken by mouth, being studied as a potential treatment for estrogen-receptor-positive breast cancer.
Also referred to as Xeloda.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this research study is to compare a combination of two drugs, capecitabine and elacestrant to capecitabine alone as a treatment for advanced estrogen receptor-positive (ER+) breast cancer. This study is designed for participants with cancer that has previously stopped responding to medication in the class of therapy called CDK 4/6 inhibitors, including palbociclib, ribociclib, or abemaciclb.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically confirmed estrogen receptor-positive (ER+), HER2-negative metastatic or locally recurrent unresectable...
- Participants must have standard of care ctDNA sequencing testing documenting ESR1 and TP53 mutation status.
- ESR1 mutations that are considered pathogenic are: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G
- TP53 mutations that are considered pathogenic as determined by a CLIA certified laboratory
- Women or men age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of capecitabine in combination with...
You likely can't join if
- Participants who have had endocrine and/or biologic therapy \< 14 days prior to entering the study or those who have not recovered from any prior...
- Participants who are receiving concurrent therapy with other investigational agents.
- Rapidly progressive, symptomatic, visceral spread of disease placing participant at risk of life- threatening complications in the short term.
- History of dihydropyrimidine dehydrogenase (DPD) deficiency. Patients with this deficiency are prone to significant toxicity from capecitabine.
- Participants with active brain metastases. Treated brain metastases that are asymptomatic and do not require systemic steroids for management of...
- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring systemic therapy, clinically significant...
See the full eligibility criteria
Who can join
- Participants must have histologically confirmed estrogen receptor-positive (ER+), HER2-negative metastatic or locally recurrent unresectable (advanced) invasive breast cancer.
- Participants must have standard of care ctDNA sequencing testing documenting ESR1 and TP53 mutation status. In patients without ESR1 mutation, this result must be from within 3 months.
- ESR1 mutations that are considered pathogenic are: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G
- TP53 mutations that are considered pathogenic as determined by a CLIA certified laboratory
- Women or men age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of capecitabine in combination with elacestrant participants \<18 years of age are excluded from this study
- Age ≥ 60 years
- Age \< 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range
- Premenopausal women who have been on a GnRH agonist for at least three consecutive months prior to study entry are eligible. Women in this group MUST remain on the GnRH agonist for the duration of protocol treatment.
- Status-post bilateral oophorectomy or total hysterectomy after adequate healing post-surgery
- Must have measurable or evaluable disease by RECIST 1.1. Must have progressed on at least one line of endocrine therapy in the metastatic setting or recurred on or within one year of adjuvant endocrine therapy
- Unrestricted number of prior endocrine therapies (with or without targeted treatment) are allowed in the advanced disease setting.
- Prior CDK4/6 inhibition is required (in adjuvant or metastatic disease), unless a CDK4/6 inhibitor is contraindicated (CDK4/6 inhibitor in combination with endocrine treatment is considered as one line of endocrine...
- Participants must have remained on a prior endocrine treatment alone or in combination with a CDK4/6 inhibitor in the metastatic setting without progression for at least 6 months prior to study entry.
- Prior alpelisib with endocrine treatment is allowed (considered as a line of endocrine treatment).
- Prior everolimus with endocrine treatment is allowed (considered a line of endocrine treatment).
- Prior capivasertib with endocrine treatment is allowed (considered a line of endocrine treatment)
- Prior fulvestrant is permitted. Prior SERM (tamoxifen, lasofoxifene) is permitted. Neither prior oral SERDs nor other next generation oral endocrine therapies (such as PROTACS) are permitted.
- No prior chemotherapy regimen or ADC is allowed in the metastatic setting.
- Participants may have received radiotherapy for palliative purposes but must not be experiencing grade \>1 treatment-related toxicities at study entry and must have completed treatment \> 14 days prior to registration.
- ECOG PS 0-1
- Absolute neutrophil count \> 1,500/µL
- Platelets \> 100,000/µL
- Hemoglobin \> 9 g/dL (transfusion is allowed to meet this criterion) Total bilirubin \< 1.5 x institutional upper limit or normal (ULN) or \< 3 institutional ULN in the presence of documented Gilbert's syndrome
- AST (SGOT)/ALT (SGPT) \< 2.5 x institutional ULN, or ≤ 5 institutional ULN for people with documented metastatic disease to the liver
- Creatinine clearance \> 50 mL/min/1.73 m2
- Women of childbearing age, women who are made postmenopausal through use of GNRH agonists, and men must agree to use adequate contraception for the duration of protocol treatment and for at least 6 months after the last...
- Age \> 60 years; or
- Age \< 60 with intact uterus and amenorrhea for 12 consecutive months or more AND estrogen (estradiol) and FSH levels are within postmenopausal range; or
- Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation
- Participants must be able to swallow and retain oral medication.
- Ability to understand and the willingness to sign a written informed consent document.
- Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at the time of screening.
- Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of...
- It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.
- Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study.
- Known history of HBV infection
- Known history of HCV infection
- As mandated by local health authority
What rules you out
- Participants who have had endocrine and/or biologic therapy \< 14 days prior to entering the study or those who have not recovered from any prior treatment-related toxicities (must recover to no more than grade 1
- Participants who are receiving concurrent therapy with other investigational agents. This is to minimize risk of drug-drug interactions and clarify etiology of future toxicities.
- Rapidly progressive, symptomatic, visceral spread of disease placing participant at risk of life- threatening complications in the short term. It is likely that these patients will not benefit from this regimen.
- History of dihydropyrimidine dehydrogenase (DPD) deficiency. Patients with this deficiency are prone to significant toxicity from capecitabine.
- Participants with active brain metastases. Treated brain metastases that are asymptomatic and do not require systemic steroids for management of symptoms are allowed if they have received SRS (7-day washout) or WBRT...
- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring systemic therapy, clinically significant cardiovascular disease including: cerebral vascular accident/stroke (\< 6...
- (1) Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy.
- (2) Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the...
- Ongoing treatment with drugs that are sensitive substrates of P-glycoprotein (dabigatran, digoxin, fexofenadine) or BRCP (rosuvastatin, sulfasalazine).
- Treatment with strong CYP3A inhibitors within 2 weeks before first study treatment administration or five elimination half-lives, whichever is longest and cannot be replaced.
- Medical conditions requiring concomitant administration of medications with a narrow therapeutic window metabolized by CYP3A and for which a dose reduction cannot be considered.
- Female participants lactating or nursing. The safety of these medications in pregnancy or breast feeding patients is unknown. Both men and women of all races and ethnic groups are eligible for this trial.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.