Clinical trial · Interventional
Endocrine Therapy Fulvestrant & Palbociclib or Aromatase Inhibitor Therapy in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery
Phase II Trial of Primary Endocrine Therapy With Combination of Fulvestrant or an Aromatase Inhibitor and Palbociclib in Elderly Patients With Hormone Responsive Breast Cancer Who Have Inoperable Tumor Or Operable Tumor But Cannot Undergo Surgery Due to Frailty Or Who Refuse Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II clinical trial studies how well fulvestrant and palbociclib works in treating older patients with breast cancer that responds to hormone treatment (hormone responsive) that cannot be removed by surgery. Estrogen can cause the growth of estrogen-receptor-positive breast cancer cells. Hormone therapy using fulvestrant may fight estrogen-receptor-positive breast cancer by blocking the use of estrogen by the tumor cells. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fulvestrant together with palbociclib may be an effective treatment for hormone responsive breast cancer.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Estrogen Receptor and/or Progesterone Receptor Positive | — | UNRESOLVED | — |
| HER2/Neu Negative | — | UNRESOLVED | — |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aromatase Inhibitors | Drug | — | UNRESOLVED |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Palbociclib | Drug | Palbociclib | ALIAS |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (fulvestrant, palbociclib)
- description
- Patients receive fulvestrant IM on days 1 and 15. Patients also receive palbociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Fulvestrant
- Other: Laboratory Biomarker Analysis
- Drug: Palbociclib
- Other: Questionnaire Administration
- Drug: Aromatase Inhibitors
Primary outcomes (1)
- measure
- Treatment failure-free survival (TFFS) defined as the proportion of study subjects who remain on treatment from the 1st day of therapy to one year
- timeFrame
- 1 year
- description
- The proportion of subjects who do not experience treatment failure at one year will be calculated along with the exact binomial confidence interval for the rate.
Secondary outcomes (14)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed invasive, estrogen receptor (ER) and/or progesterone receptor (PR)-positive, HER2 negative breast cancer; ER-and/or PR-positive breast cancer is defined by \> 10% staining by immunohistochemistry * Patients must be vulnerable or frail by Balducci Criteria or the patient is refusing breast surgery; vulnerable patients are defined as those with dependence in some instrumental activities of daily living, well controlled co-morbidities, and early symptoms of geriatric syndrome; frail patients are defined as those with three or more co-morbidities, dependence in one or more activities of daily living, or a clinically significant geriatric syndrome; geriatric syndromes include: dementia, delirium, incontinence (fecal and/or urinary), osteoporosis or spontaneous fractures, polypharmacy, visual/hearing impairment, sarcopenia and neglect or abuse * The patient's refusal to proceed with curative breast surgery has to be documented by the surgeon's and medical oncologist's note * Absolute neutrophil count (ANC) \> 1000/uL * Platelets \> 75,000/L * Serum creatinine 1.5 X institutional upper limit of normal (ULN) * Total bilirubin \< 1.5 X ULN * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) 2.5 ULN * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Prior aromatase inhibitor therapy * Evidence of distant metastases * Psychiatric illness, which would prevent the patient from giving informed consent * Patients receiving strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4)
References
Publications (0)
Data not yet available