Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Anti-Infective Agents

Paclitaxel

Tamoxifen

Doxorubicin

Liposomal doxorubicin

Albumin-Bound Paclitaxel

Taxane

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Tamoxifen 40 mg is given orally once daily until progression

Paclitaxel 80 mg/m2 is given as an 1 hour infusion every 7 days or Caelyx 40 mg/m2 is given iv, first dose over 2 hours, later doses are infused over 1 hour, administered every 4 weeks or up to a maximum dose of 550 mg/m2. Until progression

Paclitaxel or pegylated liposomal doxorubicin

Chemotherapy

Gunnar B Kristensen, Prof

A randomized study of chemotherapy versus hormonal treatment in patients with ovarian cancer resistant or refractory to platinum and taxane.

Patients with platinum-resistant invasive epithelial ovarian, fallopian tube or peritoneal cancer will be randomized 1:2 to either hormonal treatment with Tamoxifen 40 mg daily or chemotherapy of investigator's choice (weekly paclitaxel given as an 1 hour infusion of paclitaxel 80 mg/m2 or pegylated liposomal doxorubicin 40 mg/m2 given every 4 weeks).

Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane

A Randomized Study of Chemotherapy Versus Hormonal Treatment in Patients With Ovarian Cancer Resistant or Refractory to Platinum and Taxane

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Body Weight

Weight Gain

Breast Diseases

Skin Diseases

The intervention arm will be an 'algorithm-based' arm in which patients will receive personally tailored dietary recommendations, based on their microbiome, and other clinical data such as blood tests and lifestyle features.

The control arm will receive nutritional recommendations according to the standard Israeli dietary approach Mediterranean-style low-fat diet.

The diet recommendations will be provided by a certified dietitian. Participants will be asked to document their food intake and daily activities including exercise and sleep using a dedicated smartphone app throughout the intervention period.

Nutrition intervention

Gal-Yam, MD

Gal-Yam

Einav Gal-Yam, MD

Eran Segal, PhD

The Breast Cancer Personalized Nutrition (BREACPNT) study will evaluate the effect of a microbiome based personalized diet intervention on control of weight gain, glycemic response, disease outcome and various biomarkers in hormone receptor early breast cancer patients receiving adjuvant endocrine treatment.

Weight gain is a common incident in breast cancer survivors. As many as 50-96% of women experience weight gain during treatment. Endocrine treatment was identified as a risk factor for weight gain in several studies. Hence, weight management for breast cancer survivors is important for increasing adherence to therapy and lowering recurrence risk.

The essential role of the gut microbiota in modulating immune and metabolic functions in health and disease is increasingly recognized. Particularly in breast cancer (BC), diet plays an important role in creating a microbiome environment involved in estrogens metabolism. The microbiome directly affects the body's response to food.

The Personalized Nutrition Project, conducted in the Weizmann Institute of Science, showed that individuals vary greatly in their glycemic response to the same food, influenced by the involvement of functional microbial pathways. This study yielded an algorithm capable of accurately predicting personalized postprandial glycemic response (PPGR) to arbitrary meals. These results suggest that individually tailored dietary interventions help maintain normal blood glucose levels and influence microbiome diversity, which, in turn, can control weight changes.

In this phase 2 randomized trial, 200 Hormone receptor (HR) positive breast cancer patients, eligible for adjuvant endocrine therapy will be recruited to the study. Upon recruitment, subjects will provide a stool sample for microbiome analysis and will undergo continuous glucose monitoring for 2 weeks. Thereafter, patients will be randomly assigned in a 1:1 ratio to receive a personalized diet recommendation or a standard low-fat diet for 6 months. The algorithm is based on patients' microbiome analyses and other blood tests. Patient clinical records will be followed 2-3 times yearly for 5 years for DFS and BC recurrence.

The Breast Cancer Personalized Nutrition Study

A Phase 2 Single-blinded Randomized Study of Algorithm-based Personalized Nutrition Intervention Compared to Standard Diet Intervention in Patients Treated With Endocrine Therapy for Early Stage, Hormone Receptor Positive Breast Cancer

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request .

Body weight changes will be defined as the net body weight gained/lost

glycemic response control measured by the area under the glucose curve (AUC) during continuous glucose monitoring (CGM) period.

Weizmann Institute of Science

Sheba Medical Center

Deputy Head, Breast Cancer Institute

Exemestane

Letrozole

Anastrozole

Aromatase Inhibitors

Cohort 1 (premenopausal at diagnosis =\> postmenopausal at randomization) 5-year tamoxifen =\> Randomized to Arm A (switching to aromatase inhibitors for 5 years).

Cohort 1 (premenopausal at diagnosis =\> postmenopausal at randomization) 5-year tamoxifen =\> Randomized to Arm B (continuing with tamoxifen for 5 years).

Cohort 2 (postmenopausal at diagnosis) 5-year aromatase inhibitors =\> Randomized to Arm A (switching to tamoxifen for 5 years).

Cohort 2 (postmenopausal at diagnosis) 5-year aromatase inhibitors =\> Randomized to Arm B (continuing with AI for 2 years).

Antonis Valachis, MD, PhD

Andreas Nearchou, MD

Maria Annerbo, MD

Barbro Linderholm, MD, PhD

Barbro Linderholm, MD; PhD

Maria Ekholm, MD, PhD

Niklas Loman, MD, PhD

Theodoros Foukakis, MD, PhD

Alexios Matikas, MD, PhD

Anne Andersson, MD, PhD

Henrik Lindman, MD, PhD

Henrik Lindman, PD, PhD

Cecilia Nilsson, MD, PhD

Cecilia Nilsson, Md, PhD

Based on the risk of late recurrence in breast cancer patients with luminal disease with high-risk for recurrence, extended adjuvant endocrine therapy beyond 5 years is recommended as a valid treatment option. In premenopausal women at diagnosis converted to postmenopausal after the first five years of tamoxifen, two treatment strategies for extended adjuvant endocrine therapy are available, namely continuing with tamoxifen or switching to aromatase inhibitors (AI). No randomized evidence does exist and both treatment strategies are used in clinical practice. In postmenopausal women with higher recurrence risk initially treated with AI for five years, extended adjuvant therapy with additional two years of AI has shown to be as effective as additional five years of AI. However, no randomized evidence on whether a switching strategy of five-year extended tamoxifen is better compared to two-year extended AI is available. Both treatment strategies are used in clinical practice.

The primary objective of this register-based randomized trial is to investigate the overall survival between patients treated with switching strategy for extended adjuvant endocrine therapy compared to continuing with the same treatment as the initial 5 years in two different clinical scenarios:

* In premenopausal women at diagnosis who converted to postmenopausal after 5 years of tamoxifen.
* In postmenopausal women at diagnosis.

Two separate cohorts will be randomized (two arms in each study cohort)

Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer

Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer: a Registry-based Randomized Clinical Trial - SWE-Switch Breast Cancer Trial

Selected grade 3 or 4 toxicities that lead to hospitalization will be captured and analyzed for each study arm.

Assessment of overall quality of life through global health status from EORTC QLQC30 (scale 0 to 100; higher score indicates better overall quality of life)

Adherence will be calculated by using medication possession ratio (MPR; the sum of the days' supply for all fills of a given drug in a particular time period, divided by the number of days in the time period). A MPR of \>/= 80% is defined as good adherence

Mid-Sweden Regional Cancer Centre

Akademiska University Hospital, Uppsala, Sweden

Region Örebro County

Fulvestrant

Tamoxifen (pre-menopausal and male patients)

Anastrozole; 1 mg, QD, PO Fulvestrant; 500 mg, IM, day 1, 15, 29 and monthly thereafter

Anastrozole+Fulvestrant

loading dose of 40 mg, TID, PO, during 7 days, Thereafter 20 mg, QD, PO

Sabine C Linn, MD

To investigate prospectively whether short term endocrine treatment can induce molecular changes, predictive for therapy response.

We will perform a randomized, open-label, single-institution study. It will compare the efficacy of three different endocrine treatment regimens (Anastrozole +/- Fulvestrant or Tamoxifen) in changing proliferation-index and inducing apoptosis during a 2-6 week pre-operative treatment period in breast cancer patients. These results will be correlated to gene expression profiles, phosphorylation status of the ER, SNPs in CYP450 sequences, tamoxifen metabolite concentrations, changes in estrogen serum levels and protein expression patterns.

Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer

A Randomized, Prospective Trial of 2-6 Weeks Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer: Anastrozole +/- Fulvestrant or Tamoxifen Exposure - Response in Molecular Profile (AFTER-study).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane	NCT02728622	Ovarian Cancer Peritoneal Canc... Cancer of the F...	Tamoxifen Chemotherapy	18 Years -	Nordic Society of Gynaecological Oncology - Clinical Trials Unit
The Breast Cancer Personalized Nutrition Study	NCT04079270	Breast Cancer	Nutrition inter...	18 Years - 70 Years	Sheba Medical Center
Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer	NCT06223698	Breast Cancer	Letrozole Anastrozole Exemestane Tamoxifen	18 Years - 90 Years	Region Örebro County
Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer	NCT00738777	Breast Cancer	Anastrozole Anastrozole+Ful... Tamoxifen Tamoxifen	-	The Netherlands Cancer Institute
Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane	NCT02728622	Ovarian Cancer Peritoneal Canc... Cancer of the F...	Tamoxifen Chemotherapy	18 Years -	Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane	NCT02728622	Ovarian Cancer Peritoneal Canc... Cancer of the F...	Tamoxifen Chemotherapy	18 Years -	Nordic Society of Gynaecological Oncology - Clinical Trials Unit
The Breast Cancer Personalized Nutrition Study	NCT04079270	Breast Cancer	Nutrition inter...	18 Years - 70 Years	Sheba Medical Center

Spots Global Cancer Trial Database for endocrine treatment