Clinical trial · Interventional
Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer
A Phase II Trial Assessing the Tolerability of Palbociclib in Combination With Letrozole or Fulvestrant in Patients Aged 70 and Older With Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer
- 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 trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to other places in the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as letrozole or fulvestrant, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib and letrozole or fulvestrant may work better in treating patients with breast cancer. The trial will explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.
Conditions
Conditions (3)
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-positive Breast Cancer | — | UNRESOLVED | — |
| HER2/Neu Negative | — | UNRESOLVED | — |
| Stage IV Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fulvestrant | Drug | Fulvestrant | ALIAS |
| Letrozole | Drug | Letrozole | ALIAS |
| Palbociclib | Drug | Palbociclib | ALIAS |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (palbociclib, letrozole or fulvestrant)
- description
- Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Palbociclib
- Drug: Letrozole
- Drug: Fulvestrant
- Other: Questionnaire Administration
- Other: Quality-of-Life Assessment
Primary outcomes (1)
- measure
- Incidence of Adverse Events
- timeFrame
- 6 months
- description
- Defined as the proportion of patients with documentation of grade 3 - 5 toxicity (regardless of attribution using the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v.\] 5.0 criteria). A 95% binomial confidence interval for single proportions will be constructed for the severe toxicity rate during treatment. Univariate relationships between the primary endpoint and various pre-treatment patient characteristics such as anemia, self-assessed functional status, or social support will be described via cross-tabulation and Fisher's exact testing. Exploratory logistic regression modeling, with limited generalizability due to the modest sample size, will be used to assess the relative contributions of these variables impact the likelihood of developing a severe toxicity during treatment. The strength of this association will be expressed in terms of an odds ratio and its associated 95% confidence interval.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Documentation of disease: estrogen receptor positive and/or progesterone receptor (PR) positive, HER2 negative metastatic breast cancer; histologic confirmation is required * Measurable disease or non-measurable disease * Planning to begin palbociclib for metastatic disease; one prior line of endocrine therapy and/or chemotherapy for metastatic disease is allowed; patients may begin or have already begun endocrine therapy before they start palbociclib treatment, but no more than two weeks prior to registration * No prior therapy with a CDK inhibitor * Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE grade =\< 1 (except alopecia) or to baseline toxicities prior to previous therapy or surgical procedures, prior to registration * No untreated brain metastases; patients with treated brain metastases must have completed treatment with steroids to be eligible * No known interstitial lung disease * No second malignancies other than non-melanoma skin cancers or cervical carcinoma in situ; however, patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for \>= 3 years * No active infection requiring treatment with antibiotics * Patients must be able to swallow and retain oral medication * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * Patients must be able to read and comprehend English or Spanish * Absolute neutrophil count (ANC) \>= 1500/mm\^3 (1.5 x 10\^9/L) * Platelet count \>= 100,000/mm\^3 (100 x 10\^9/L) * Creatinine clearance \>= 30 ml/min calculated using the Cockcroft-Gault formula * Total serum bilirubin =\< 1.5 upper limit of normal (ULN) (\< 3 ULN if Gilbert's disease) * Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =\< 3 x ULN (=\< 5.0 x ULN if liver metastases present) * Alkaline phosphatase =\< 2.5 x ULN (=\< 5 x ULN if bone or liver metastases present)
References
Publications (1)
- DERIVEDSedrak MS, Lee MK, Ji J, Satele DV, Freedman RA, Poorvu PD, O'Connor T, Williams GR, Hopkins JO, Muss HB, Cohen HJ, Partridge AH, Carey LA, Chow SL, Subbiah N, Le-Rademacher J, Jatoi A. Palbociclib in adults aged 70 years and older with advanced breast cancer: A phase 2 multicenter trial (Alliance A171601). J Geriatr Oncol. 2024 Jul;15(6):101813. doi: 10.1016/j.jgo.2024.101813. Epub 2024 Jun 8. PMID 38852379